# https://fsca.swissmedic.ch/mep/#?onlyUpdates=false&sort=PUBLICATION_DATE&direction=DESC 
swissmedicRef,publicationDate,statusDate,reason,manufacturer,tradename,description,model,lot,sn,softwareVersion,directLink
Vk_20250425_35,2025-04-30,2025-04-30,,"Ortho-Clinical Diagnostics","ORTHO VISION Analyzer","IVD: Blood group/antibody screening analyser IVD",6904579,,,"5.16 and below","https://fsca.swissmedic.ch/mep/#?q=Vk_20250425_35"
Vk_20250425_35,2025-04-30,2025-04-30,,"Ortho-Clinical Diagnostics","ORTHO VISION Max Analyzer","IVD: Blood group/antibody screening analyser IVD",6904578,,,"5.16 and below","https://fsca.swissmedic.ch/mep/#?q=Vk_20250425_35"
Vk_20250417_28,2025-04-22,2025-04-30,"Added new language","DH Healthcare GmbH","ORBIS Medication 3.x","MD: General Medicine Instruments - Other",,,,03.20.04.00,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250417_28"
Vk_20250417_17,2025-04-29,2025-04-29,,"GRI Medical Electronic Technology Co Ltd","Eye wick","MD: Ophthalmic sponge",581147,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250417_17"
Vk_20250425_29,2025-04-29,2025-04-29,,"Labcon North America","X500 U-Pette Blood Dispenser for Point of Care Test","IVD: Blood transfusion set, non-exchange",7404372,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250425_29"
Vk_20250425_29,2025-04-29,2025-04-29,,"Labcon North America","X100 C-Pette Blood Dispenser for Point of Care Test","IVD: Blood transfusion set, non-exchange",17424372,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250425_29"
Vk_20250314_26,2025-03-18,2025-04-29,"Added new language",PHYSIO-ASSIST,SIMEOX,"MD: Respiratory And Anaesthesia Devices - Other",SIMEOX_H,,,9,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250314_26"
Vk_20250416_54,2025-04-29,2025-04-29,,"Welch Allyn, Inc.","Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff","MD: Aneroid manual sphygmomanometer","DS44-11, DS44-11C, DS58-11, DS58-MC, 5098-27, 5098-28",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250416_54"
Vk_20250416_54,2025-04-29,2025-04-29,,"Welch Allyn, Inc.","Welch Allyn 2 Piece Reusable Blood Pressure Cuff Kits","MD: Blood pressure cuff, reusable"," 5082-44, 47-22-189, 45-23-189, 45-15-389",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250416_54"
Vk_20250402_12,2025-04-08,2025-04-29,"FSN French languge","Coloplast A/S","Coloplast Drainage bag 1-piece open sterile","MD: One-piece intestinal ostomy bag, open-ended","02210, 02215, 02220","10105555, 10127568, 10165802, 10181624, 10158631, 10190401",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250402_12"
Vk_20250422_42,2025-04-29,2025-04-29,,"Remote Diagnostic Technologies Ltd.","Tempus Pro Patient Monitor","MD: Multiple vital physiological parameter monitoring system, clinical","see FSN",,,"see FSN","https://fsca.swissmedic.ch/mep/#?q=Vk_20250422_42"
Vk_20250425_23,2025-04-29,2025-04-29,,"Stryker Instruments","Otopore & Nasopore","MD: EMDN=35288","see FSN","see FSN","see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250425_23"
Vk_20250417_03,2025-04-22,2025-04-25,"Added new language","IBA Dosimetry GmbH","myQA iON","MD: Dosimeters ",MQ10-000,,,All,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250417_03"
Vk_20250414_11,2025-04-15,2025-04-23,"Added new language","DH Healthcare GmbH","ORBIS Medication 3.x","MD: General Medicine Instruments - Other",,,,03.16.08.00,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250414_11"
Vk_20250417_20,2025-04-23,2025-04-23,,"Remote Diagnostic Technologies Ltd.","Tempus Pro Patient Monitor","MD: Multiple vital physiological parameter monitoring system, clinical","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250417_20"
Vk_20250422_06,2025-04-23,2025-04-23,,"LeMaitre Vascular, Inc.","TufTex Embolectomy Catheter","MD: Embolectomy Catheters","1651-34, 1651-38, 1651-44, 1651-48, 1651-64, 1651-68, 1651-78, 1651-84, 1651-88","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250422_06"
Vk_20250422_06,2025-04-23,2025-04-23,,"LeMaitre Vascular, Inc.","Pruitt Occlusion Catheter","MD: Intravascular occluding balloon catheter, image-guided","2103-36, 2103-46, 2103-56","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250422_06"
Vk_20250422_06,2025-04-23,2025-04-23,,"LeMaitre Vascular, Inc.","Pruitt Irrigation Occlusion Catheter","MD: Intravascular occluding balloon catheter, image-guided",2102-09,"See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250422_06"
Vk_20250415_52,2025-04-22,2025-04-22,,"GE Healthcare Finland Oy","Centricity High Acuity Critical Care","MD: Patient health record information system",,,,"5.8.2 through 5.8.4","https://fsca.swissmedic.ch/mep/#?q=Vk_20250415_52"
Vk_20250415_52,2025-04-22,2025-04-22,,"GE Healthcare Finland Oy","Centricity High Acuity Anesthesia","MD: Patient health record information system",,,,"5.8.2 through 5.8.4","https://fsca.swissmedic.ch/mep/#?q=Vk_20250415_52"
Vk_20250416_21,2025-04-22,2025-04-22,,"Cook Incorporated","Check-Flo Performer Introducer","MD: Vascular catheter introduction set, nonimplantable","RCFW-14.0-38-30-RB; G08957",16376242,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250416_21"
Vk_20250417_07,2025-04-22,2025-04-22,,"MAQUET Cardiopulmonary GmbH","Cardiohelp System - HKH 8820 Wall Holder","MD: EMDN=35099","701045366; see Model number","all devices affected",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250417_07"
Vk_20250416_36,2025-04-22,2025-04-22,,"Cook Incorporated","Tornado Embolization Microcoil","MD: Non-neurovascular embolization coil","MWCE-18S-3/2-TORNADO and MWCE-18S-4/2-TORNADO; G08261 and G08357","MWCE-18S-3/2-TORNADO: 16196534, 16183146, 16183145, 16196532, 16196535, 16233647, 16233648, 16233649, MWCE-18S-4/2-TORNADO: 16178639",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250416_36"
Vk_20250417_01,2025-04-22,2025-04-22,,"Siemens Healthcare Diagnostics Inc.","ADVIA Centaur HCY Calibrator","IVD: Homocysteine IVD, calibrator",10310376,"86237A74, 44207A75",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250417_01"
Vk_20250417_01,2025-04-22,2025-04-22,,"Siemens Healthcare Diagnostics Inc.","Atellica IM Homocysteine Calibrator","IVD: Homocysteine IVD, calibrator",10995498,"86236A74, 44206A75",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250417_01"
Vk_20250414_12,2025-04-17,2025-04-17,,"Siemens Healthcare Diagnostics Products GmbH","N Latex FLC LAMBDA","IVD: Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry",10482438,"473298; 473298A",n/a,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250414_12"
Vk_20250404_27,2025-04-08,2025-04-17,"Added new language","Stryker Instruments","System 6/7/8/9 Reciprocating / Sternum Saw","MD: Bone/joint surgical power tool motor, electric","See FSN","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250404_27"
Vk_20250414_08,2025-04-17,2025-04-17,,"Integra LifeSciences Corp","Codman Disposable Perforator","MD: Automatic cranial perforator, single-use","26-1221, 26-1230","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250414_08"
Vk_20240109_10,2024-01-17,2025-04-17,"Added new language","Philips Medical Systems Nederland B.V.","Philips Intera, Achieva, Ingenia CX","MD: Full-body MRI system, superconducting magnet","See FSN",,"See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240109_10"
Vk_20250404_21,2025-04-16,2025-04-16,,"Welch Allyn, Inc.","Welch Allyn Connex Vital Signs Monitor (CVSM)","MD: General-purpose multi-parameter bedside monitor","see Annex B of FSN",,all,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250404_21"
Vk_20250404_21,2025-04-16,2025-04-16,,"Welch Allyn, Inc.","Welch Allyn Connex Spot Monitor Accessory Power Management Stand (APM)","MD: Secondary battery","75-HCA-CTB, 7000-APM, 75-HCA-MTB",,all,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250404_21"
Vk_20250416_55,2025-04-16,2025-04-16,,Cepheid,"Xpert BCR-ABL Ultra","IVD: Philadelphia chromosome/BCR-ABL mRNA expression IVD, kit, nucleic acid technique (NAT)",GXBCRABL-10,"lot 40801 / batch 1001420864",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250416_55"
Vk_20250416_55,2025-04-16,2025-04-16,,Cepheid,"Xpert BCR/ABL Ultra p190","IVD: Tests For Acquired Genetic Or Chromosomal Alterations - Other","GXBCRABLP190 -CE-10","lot 02503 / batch 1001405396 ; lot 02601 ; batch 1001416944",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250416_55"
Vk_20250408_49,2025-04-16,2025-04-16,,Alchimia,"Got multi SF6","MD: gas container","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250408_49"
Vk_20250408_49,2025-04-16,2025-04-16,,Alchimia,"Got multi C3F8","MD: gas container","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250408_49"
Vk_20250408_49,2025-04-16,2025-04-16,,Alchimia,"Got multi C2F6","MD: gas container","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250408_49"
Vk_20250319_22,2025-03-26,2025-04-16,"Added new language","Immucor GTI Diagnostics, Inc.","LIFECODES PF4 Enhanced & LIFECODES PF4 IgG","IVD: Platelet factor 4-heparin complex antibody IVD, kit, enzyme immunoassay","HAT13G, HAT45G, X-HAT13, X-HAT45","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250319_22"
Vk_20250411_15,2025-04-16,2025-04-16,,"Philips Light & Health, Philips N.V.","IntelliSpace Cardiovascular","MD: Radiology picture archiving and communication system workstation",830089,,,"6.x, 7.x and 8.x","https://fsca.swissmedic.ch/mep/#?q=Vk_20250411_15"
Vk_20250410_17,2025-04-16,2025-04-16,,"Philips Medizinsysteme Böblingen GmbH","Microstream Advance, VitaLine, FilterLine","MD: Nasal oxygen cannula, carbon-dioxide-sampling","See FSN",,"See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250410_17"
Vk_20250409_02,2025-04-15,2025-04-15,,"Beckman Coulter , Inc.","DxC 500i Clinical Analyzer","IVD: Chemistry / Immunochemistry Instruments","C13252, C63521, C63522",,,"1.3.0 and 1.3.2","https://fsca.swissmedic.ch/mep/#?q=Vk_20250409_02"
Vk_20250411_42,2025-04-15,2025-04-15,,"Corin Medical Ltd.",MiniHip,"MD: Coated hip femur prosthesis, modular","see FSN","see FSN",N/A,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250411_42"
Vk_20240514_24,2024-05-22,2025-04-14,"Phase II Produkte Rückruf","Medtronic Inc.","Ascenda Intrathecal Catheter","AIMD: Lumbar cerebrospinal fluid drainage catheterization kit","8780, 8781",All,All,N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240514_24"
Vk_20240514_24,2024-05-22,2025-04-14,"Phase II Produkte Rückruf","Medtronic Inc.","Ascenda Intrathecal Catheter Pump Segment Revision Kit","AIMD: Lumbar cerebrospinal fluid drainage catheterization kit",8784,All,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240514_24"
Vk_20250406_01,2025-04-14,2025-04-14,,"Gyrus ACMI Inc.","Soltive Laser System","MD: General/multiple surgical solid-state laser system","TFL-PLS, TFL-SLS",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250406_01"
Vk_20250410_49,2025-04-11,2025-04-11,,"GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC","Venue Go, Venue Fit","MD: General-purpose ultrasound imaging system","See FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250410_49"
Vk_20250403_29,2025-04-10,2025-04-10,,"BioFire Diagnostics, LLC","FilmArray Blood Culture Identification (BCID) Panel","IVD: Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry",RFIT-ASY-0147,"All BCID2 Panel lots manufactured since October 12, 2022.",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250403_29"
Vk_20250403_46,2025-04-10,2025-04-10,,Wandercraft,"Atalante X","MD: lower-limb exoskeleton",,,V5_ABB,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250403_46"
Vk_20250325_29,2025-04-02,2025-04-10,"Added new language","SPINEART SA","JULIET Ti TL TRANSFORAMINAL LUMBAR TI CAGE","MD: Metallic spinal interbody fusion cage","see FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250325_29"
Vk_20250403_54,2025-04-09,2025-04-09,,"DH Healthcare GmbH","DeepUnity PACSonWEB","MD: Picture Archiving And Communication Systems",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250403_54"
Vk_20250404_01,2025-04-08,2025-04-08,,"Philips Electronics Nederland B.V.","Big Bore RT","MD: Full-body CT system",728242,,"768002, 763006",4.8.0.10430,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250404_01"
Vk_20250404_01,2025-04-08,2025-04-08,,"Philips Electronics Nederland B.V.","Brilliance CT Big Bore Oncology","MD: Full-body CT system"," 728243, 728244",,"7038, 7868",4.8.0.10430,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250404_01"
Vk_20250404_38,2025-04-08,2025-04-08,,"Medicalgorithmics S.A.","Unified Arrhythmia Diagnostic System PocketECG IV","MD: Telemetric electrocardiographic ambulatory recorder",P4TR-CA-ADS,,TR4923-01784A,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250404_38"
Vk_20250402_17,2025-04-08,2025-04-08,,"Siemens Healthcare Diagnostics Inc.","Stratus CS Acute Care cTnI TestPak","IVD: Troponin I IVD, kit, fluorescent immunoassay",10445071,"From Lot# 234337002 and forward",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250402_17"
Vk_20250407_09,2025-04-08,2025-04-08,,"Mesalvo Freiburg GmbH",MEONA,"MD: Medical Device Software - Not Included In Other Classes","Release V",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250407_09"
Vk_20250402_05,2025-04-08,2025-04-08,,"Datex-Ohmeda Inc.","Carestation 600 and 750 Series","MD: Anaesthesia workstation, general-purpose","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250402_05"
Vk_20250403_27,2025-04-08,2025-04-08,,"Klinika Medical GmbH",KliniTray,"MD: Clinical Use Trays And Bowls","2001105, 2001155, 2001205, 2001255","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250403_27"
Vk_20250408_01,2025-04-08,2025-04-08,,"Raumedic AG",NEUROVENT-PTO,"MD: Intracerebral sensor catheter, short-term",095008-001,,"See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250408_01"
Vk_20250325_11,2025-04-02,2025-04-03,"Added new language","Abbott Molecular Inc.","Alinity m System","IVD: Nucleic Acid Testing Integreted Extration /amplification /detection Systems",08N53,,all,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250325_11"
Vk_20250324_19,2025-03-26,2025-04-03,"Added new language","Waldemar Link GmbH & Co. KG","LinkSymphoKnee System Femoral and Tibial augments","MD: Knee arthroplasty wedge","See FSN","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250324_19"
Vk_20250303_18,2025-03-25,2025-04-03,"DE Version mit Datum","Schiller AG","FRED Easyport","MD: Non-rechargeable public semi-automated external defibrillator","3.940050; 0.900000",,"All devcies",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250303_18"
Vk_20250331_31,2025-04-03,2025-04-03,,"Fresenius Kabi AG","CompoStop Platelet Storage Systems","MD: Blood donor set, double-pack","FD51600, FD51600AB, FT52600, GT52600, GT526NL","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250331_31"
Vk_20250331_21,2025-04-02,2025-04-02,,"Beckman Coulter , Inc.","DxI 9000 Access Immunoassay Analyzer","IVD: Chemiluminescent immunoassay analyser IVD",C11137,,,"1.20 and below","https://fsca.swissmedic.ch/mep/#?q=Vk_20250331_21"
Vk_20250326_01,2025-04-01,2025-04-01,,"PHC Corporation","PATHFAST hs-cTnI","IVD: Cardiac Markers",PF1241-K,A4527,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250326_01"
Vk_20250325_28,2025-04-01,2025-04-01,,"Hill-Rom, Inc.","TruSystem 7500","MD: Universal operating table, electromechanical","P7520A23, P7520A45, P7520A21, P7520A39, P7520A31, P7520A19, P7520A15, P7520A24S; NA",,"Refer to Attachment A",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250325_28"
Vk_20250325_12,2025-04-01,2025-04-01,,"Beckman Coulter , Inc.","DxC 500i Clinical Analyzer","IVD: Chemistry / Immunochemistry Instruments","C63521, C63522",,,"1.3.0 and 1.3.2","https://fsca.swissmedic.ch/mep/#?q=Vk_20250325_12"
Vk_20240530_22,2024-06-11,2025-03-31,"follow-up communication software update","Radiometer Medical","ABL800 Basic","IVD: Metabolic profile clinical chemistry analyser IVD, stationary, automated",393-800,"All analyzers",N/A,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240530_22"
Vk_20240530_22,2024-06-11,2025-03-31,"follow-up communication software update","Radiometer Medical","ABL800 FLEX","IVD: Metabolic profile clinical chemistry analyser IVD","393- 801","All analyzers",,N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240530_22"
Vk_20250109_18,2025-02-06,2025-03-31,"Added new language","Dexcom, lnc.","Dexcom G6 CGM System Receiver","MD: Percutaneous interstitial-fluid glucose monitoring system, electrochemical","MT24078-1 (mg/dL), MT24078-2 (mmol/L); STK-GS-013, STR-GS-004, STK-GS-109, STR-GS-102",,"All serial number for the affected models","SW11712 (mg/dL), SW11713 (mmol/L)","https://fsca.swissmedic.ch/mep/#?q=Vk_20250109_18"
Vk_20250314_07,2025-03-29,2025-03-29,,"Cantel Medical (Italy) S.r.l.","MEDISA Automated Endoscope Reprocessor (AER)","MD: Endoscope washer-disinfector (chemical)",MEDISA7,,"62467 and 62474",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250314_07"
Vk_20250320_01,2025-03-28,2025-03-28,,"Carnamedica Sp. z o.o.","Belzer UW","MD: Donor-organ/tissue/cell preservation solution","BUWC, BUWC2000",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250320_01"
Vk_20250320_01,2025-03-28,2025-03-28,,"Carnamedica Sp. z o.o.","Belzer MPS","MD: Donor-organ/tissue/cell preservation solution","BMPSC, BMPSC2000",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250320_01"
Vk_20250320_01,2025-03-28,2025-03-28,,"Carnamedica Sp. z o.o.",StoreProtect,"MD: Donor-organ/tissue/cell preservation solution","SPRT, SPRT2000",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250320_01"
Vk_20250320_01,2025-03-28,2025-03-28,,"Carnamedica Sp. z o.o.",PumpProtect,"MD: Donor-organ/tissue/cell preservation solution","PPRT, PPRT2000",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250320_01"
Vk_20250320_01,2025-03-28,2025-03-28,,"Carnamedica Sp. z o.o.","StoreProtect Plus","MD: Donor-organ/tissue/cell preservation solution","SPRT-P, SPRT-P2000",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250320_01"
Vk_20250320_01,2025-03-28,2025-03-28,,"Carnamedica Sp. z o.o.",LungProtect,"MD: Donor-organ/tissue/cell preservation solution","LPRT, LPRT2000",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250320_01"
Vk_20250320_01,2025-03-28,2025-03-28,,"Carnamedica Sp. z o.o.",CelProtect,"MD: Donor-organ/tissue/cell preservation solution","CPRT, CPRT2000",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250320_01"
Vk_20250320_01,2025-03-28,2025-03-28,,"Carnamedica Sp. z o.o.",PlegiStore,"MD: Donor-organ/tissue/cell preservation solution","PLST, PLST2000",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250320_01"
Vk_20250318_01,2025-03-26,2025-03-26,,"Maquet Cardiovascular, LLC","VasoView Hemopro 2","MD: Flexible endoscopic scissors, reusable","VH-4000 and VH-4001","All unexpired lots",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250318_01"
Vk_20250324_27,2025-03-26,2025-03-26,,"ROCAMED FRANCE","Endoflow II Irrigation and Warming System tubings","MD: Drainage And Fluid Collection Devices - Other","MEN01, MEN02",,1607-442,2.16d,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250324_27"
Vk_20250325_31,2025-03-26,2025-03-26,,"Beckman Coulter , Inc.","DxC 500i Clinical Analyzer","IVD: Chemistry / Immunochemistry Instruments","C13252, C63521, C63522",,,"1.3.0 and 1.3.2","https://fsca.swissmedic.ch/mep/#?q=Vk_20250325_31"
Vk_20240726_01,2024-07-30,2025-03-26,Reminder,"ZEVEX Inc.","FreeGo enteral feeding pump","MD: Enteral feeding pump",S400,,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240726_01"
Vk_20250317_04,2025-03-25,2025-03-25,,"Abbott Diagnostics Scarborough, Inc.","ID NOW RSV 24T","IVD: SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)",435000,"see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250317_04"
Vk_20250317_04,2025-03-25,2025-03-25,,"Abbott Diagnostics Scarborough, Inc.","ID NOW COVID-19 24 Test Kit","IVD: SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)","192000; 193000","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250317_04"
Vk_20250317_04,2025-03-25,2025-03-25,,"Abbott Diagnostics Scarborough, Inc.","ID NOW Influenza A/B 2 24T","IVD: SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)",427000,"see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250317_04"
Vk_20250319_09,2025-03-25,2025-03-25,,"GE Healthcare","Centricity PACS-IW","MD: Radiological PACS software",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250319_09"
Vk_20250319_09,2025-03-25,2025-03-25,,"GE Healthcare","Centricity Radiology RA600","MD: Medical image management system",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250319_09"
Vk_20250319_09,2025-03-25,2025-03-25,,"GE Healthcare","Centricity Cardiology CA1000","MD: Medical image management system",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250319_09"
Vk_20250319_09,2025-03-25,2025-03-25,,"GE Healthcare","Centricity Universal Viewer","MD: Medical image management system",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250319_09"
Vk_20250320_26,2025-03-25,2025-03-25,,"pro med instruments GmbH","DORO Easy-Connect Navigationsadapter, BRAINLAB","MD: Skull clamp",1204.002,"All products delivered up to and including January 2025 are affected.","All products delivered up to and including January 2025 are affected.",-,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250320_26"
Vk_20250318_16,2025-03-25,2025-03-25,,"GE Medical Systems, LLC","Revolution Apex series","MD: Full-body CT system","see FSN",,"see FSN","see FSN","https://fsca.swissmedic.ch/mep/#?q=Vk_20250318_16"
Vk_20250318_16,2025-03-25,2025-03-25,,"GE Medical Systems, LLC","Revolution CT","MD: Full-body CT system","see FSN",,"see FSN","see FSN","https://fsca.swissmedic.ch/mep/#?q=Vk_20250318_16"
Vk_20250321_09,2025-03-25,2025-03-25,,"Epocal Inc.","Epoc BGEM Test Card","IVD: Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent","see FSN","see FSN",all,"see FSN","https://fsca.swissmedic.ch/mep/#?q=Vk_20250321_09"
Vk_20250321_09,2025-03-25,2025-03-25,,"Epocal Inc.","Epoc BGEM Crea Testkarte","IVD: Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent","see FSN","see FSN",all,"see FSN","https://fsca.swissmedic.ch/mep/#?q=Vk_20250321_09"
Vk_20250324_04,2025-03-25,2025-03-25,,"Beckman Coulter , Inc.","DxC 500 AU Clinical Chemistry Analyzer","IVD: Multiple clinical chemistry analyser IVD, laboratory","C63519, C63520",,"see FSN","V1.3, V1.4, V1.4.1, V1.4.2","https://fsca.swissmedic.ch/mep/#?q=Vk_20250324_04"
Vk_20250318_33,2025-03-25,2025-03-25,,"Amplitude S.A.S.","EVOK Femoral Stem - Standard Offset - Collarless - Cemented - Taper12/14 - Size 8","MD: Uncoated hip femur prosthesis, modular",1-0196708,"see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250318_33"
Vk_20250319_08,2025-03-25,2025-03-25,,"Medtronic CoreValve LLC","EVOLUT FX PLUS VALVE","MD: Stented Biological Aortic Valves For Percutaneous Implant - Valve Tissue Of Animal Origin","EVFXPLUS-23, EVFXPLUS-26, EVFXPLUS-29, EVFXPLUS-34",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250319_08"
Vk_20250319_08,2025-03-25,2025-03-25,,"Medtronic CoreValve LLC","EVOLUT FX VALVE","MD: Stented Biological Aortic Valves For Percutaneous Implant - Valve Tissue Of Animal Origin","EVOLUTFX-23, EVOLUTFX-26, EVOLUTFX-29, EVOLUTFX-34",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250319_08"
Vk_20250319_08,2025-03-25,2025-03-25,,"Medtronic CoreValve LLC","EVOLUT PRO PLUS VALVE","MD: Stented Biological Aortic Valves For Percutaneous Implant - Valve Tissue Of Animal Origin","EVPROPLUS-23, EVPROPLUS-26, EVPROPLUS-29, EVPROPLUS-34",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250319_08"
Vk_20250319_02,2025-03-25,2025-03-25,,"B. Braun Avitum AG","DIASTREAM IQ PREMIUM HD SNCO","MD: Haemodialysis blood tubing set, single-use",7211127,"22E04534P, 22F07534P, 22I28534P, 22H03534P, 23C09534P, 23E09F5PA0, 23K05F5PA0, 23M07F5PA0, 24A24F5PA0, 24B20F5PA0, 24D17F5PA0, 24D24F5PA0, 24D25F5PA0",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250319_02"
Vk_20241011_20,2024-10-15,2025-03-24,"additional information","Datex-Ohmeda Inc.","Giraffe OmniBed Carestation","MD: Conventional infant incubator",,,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241011_20"
Vk_20241011_20,2024-10-15,2025-03-24,"additional information","Datex-Ohmeda Inc.","Giraffe OmniBed","MD: Conventional infant incubator",,,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241011_20"
Vk_20250318_02,2025-03-21,2025-03-21,,"Abbott Medical","Amplatzer Torqvue","MD: Cardiac occluder delivery kit","9-TVLP4F90/060, 9-TVLP4F90/080, 9-TVLPC4F90/080","10064658, 10080105, 10306815, 9141186",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250318_02"
Vk_20250305_08,2025-03-20,2025-03-20,,"Defibtech, LLC",LifeLine,"MD: Non-rechargeable public automated external defibrillator",DDU-E2200,,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250305_08"
Vk_20250319_01,2025-03-20,2025-03-20,,"Beckman Coulter , Inc.","DxC 500i Clinical Analyzer","IVD: Chemistry / Immunochemistry Instruments","C13252, C63521, C63522",,,"SW 1.3.0 and 1.3.2","https://fsca.swissmedic.ch/mep/#?q=Vk_20250319_01"
Vk_20250314_23,2025-03-20,2025-03-20,,"Beckman Coulter , Inc.","DxC 500i Clinical Analyzer","IVD: Chemistry / Immunochemistry Instruments","C13252, C63521, C63522",,,"see FSN","https://fsca.swissmedic.ch/mep/#?q=Vk_20250314_23"
Vk_20230306_19,2023-03-07,2025-03-20,"PUR-Schlauch mit VMQ ersetzen und neue Sprache","MAQUET Cardiopulmonary GmbH","Heater-Cooler Unit HCU 40 High Voltage","MD: Cardiopulmonary bypass system heat exchanger, reusable",701044054,,all,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20230306_19"
Vk_20250305_04,2025-03-20,2025-03-20,,"Defibtech, LLC",LifeLine,"MD: Non-rechargeable public automated external defibrillator","DDU-E100, DDU-E2300, DDU-E2450",All,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250305_04"
Vk_20250318_36,2025-03-20,2025-03-20,,"Beckman Coulter , Inc.","DxC 500 AU Clinical Chemistry Analyzer","IVD: Multiple clinical chemistry analyser IVD, laboratory","C63519, C63520",,"see FSN","V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3","https://fsca.swissmedic.ch/mep/#?q=Vk_20250318_36"
Vk_20250226_04,2025-03-19,2025-03-19,,"Zoll Medical Corporation","Powerheart AED G5","MD: Non-rechargeable public automated external defibrillator",G5X-XXX,,,NA,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250226_04"
Vk_20250311_12,2025-03-18,2025-03-18,,"Medtronic Xomed Inc","PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB","MD: Nerve-locating system",NIM4CPB1RF,,,"V1.5.4 and V1.6.5","https://fsca.swissmedic.ch/mep/#?q=Vk_20250311_12"
Vk_20250311_12,2025-03-18,2025-03-18,,"Medtronic Xomed Inc","CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED","MD: Nerve-locating system",NIM4CM01RF,,,"V1.5.4 and V1.6.5","https://fsca.swissmedic.ch/mep/#?q=Vk_20250311_12"
Vk_20250311_12,2025-03-18,2025-03-18,,"Medtronic Xomed Inc","PATIENT INTERFACE NIM4CPB1 NIM 4.0","MD: Nervous System Monitoring Systems",NIM4CPB1,,All,"V1.5.4 and V1.6.5","https://fsca.swissmedic.ch/mep/#?q=Vk_20250311_12"
Vk_20250311_12,2025-03-18,2025-03-18,,"Medtronic Xomed Inc","CONSOLE NIM4CM01 NIM 4.0","MD: Nervous System Monitoring Systems",NIM4CM01,,All,"V1.5.4 and V1.6.5","https://fsca.swissmedic.ch/mep/#?q=Vk_20250311_12"
Vk_20250212_30,2025-03-18,2025-03-18,,"Paul Hartmann AG","Care Set Obstetrics 0001 Kocher Forceps","MD: Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use","see FSN","see FSN","see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250212_30"
Vk_20250312_15,2025-03-18,2025-03-18,,"Baxter Medical Systems GmbH + Co. KG","TruSystem 7500","MD: Universal operating table, electromechanical","1704695, 1717020, 1717021, 1717022, 1717023, 1730732, 1773204, 1854085, 1854086, 1854087, 1854088, 4091000; ",NA,"All manufactured before 14-Nov-2024",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250312_15"
Vk_20250314_02,2025-03-18,2025-03-18,,"Thoratec Corporation","HeartMate 3 Mobile Power Unit (MPU)","MD: Implantable ventricular circulatory assist system","107758, 107758UK, L107758",,"See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250314_02"
Vk_20250314_32,2025-03-18,2025-03-18,,"Siemens Healthcare Diagnostics Inc.","Atellica CH Revised C-Reactive Protein (RCRP)","IVD: C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry",11537223,N/A,N/A,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250314_32"
Vk_20250306_21,2025-03-14,2025-03-14,,"Radiometer Medical","ABL90 FLEX","IVD: Metabolic profile clinical chemistry analyser IVD",393-090,,,"RWIN10 1.0 and 1.1","https://fsca.swissmedic.ch/mep/#?q=Vk_20250306_21"
Vk_20250306_21,2025-03-14,2025-03-14,,"Radiometer Medical","ABL90 FLEX PLUS","IVD: Metabolic profile clinical chemistry analyser IVD",393-092,,,"RWIN10 1.0 and 1.1","https://fsca.swissmedic.ch/mep/#?q=Vk_20250306_21"
Vk_20250307_10,2025-03-11,2025-03-14,"Added new language","Institut Straumann AG","TLX/TLC Guided Implant Driver, ratchet, SP","MD: Dental implant holding endpiece, reusable",037.3002,"LGMZ8, GLKJ9",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250307_10"
Vk_20250225_25,2025-03-04,2025-03-13,,"Stryker Endoscopy","CINCHLOCK FLEX ANCHOR WITH INSERTER","MD: Tendon/ligament bone anchor, non-bioabsorbable",CAT02643,"See in the attached FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250225_25"
Vk_20240819_23,2024-08-20,2025-03-12,,"Datex-Ohmeda Inc.","Aisys CS2, Avance CS2, Avance CS2 Pro, Aisys, Avance, Amingo, Aespire 100, Aespire View, Aespire 7900, and Aespire 7100 anesthesia devices equipped with the Auxiliary Common Gas Outlet (ACGO)","MD: Anaesthesia workstation, general-purpose",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240819_23"
Vk_20250305_21,2025-03-12,2025-03-12,,"Beckman Coulter , Inc.","Access Vitamin B12","IVD: Vitamin B12 IVD, kit, radioimmunoassay",33000,439850,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250305_21"
Vk_20250306_02,2025-03-12,2025-03-12,,"Immunotech s.r.o.","Inhibin B Gen II ELISA","IVD: TUMOUR MARKERS",A81303,"241022C, 241022D, 241108C, 241205C, 241212C",N/A,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250306_02"
Vk_20250304_12,2025-03-12,2025-03-12,,"Welch Allyn, Inc.","Welch Allyn non-automated blood pressure gauges","MD: Aneroid manual sphygmomanometer","See FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250304_12"
Vk_20250305_19,2025-03-11,2025-03-11,,"BioFire Diagnostics, LLC","BioFire FilmArray Pneumonia plus (PN plus) Panel","IVD: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)","RFIT-ASY-0143 (PNplus, 30-pack)",0979424,,N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250305_19"
Vk_20250304_21,2025-03-11,2025-03-11,,"XENIOS AG","Hilite oxygenator","MD: Cardiopulmonary bypass system blood tubing set","F32000014, F32000019, F30000072, F30020007, F30000071, F30000554, F30000025, F30000019, F00012619","Siehe FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250304_21"
Vk_20250217_19,2025-02-18,2025-03-11,"attachment 1 in German and French now available","Biosense Webster Inc","VARIPULSE Bi-Directional Catheter","MD: Arrhythmogenic Foci Ablation Leads Via Other Energy Sources",D141201,"All lots",,N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250217_19"
Vk_20250306_01,2025-03-11,2025-03-11,,"GE Healthcare Tianjin Company Limited","SIGNA Creator, SIGNA Explorer, Brivo MR355, Optima MR360","MD: Full-body MRI system, superconducting magnet",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250306_01"
Vk_20250305_22,2025-03-11,2025-03-11,,"Medtronic Inc.","Stimulation RC Clinician Programmer Application","MD: Neurostimulators Programmers - Software Accessories",A71400,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250305_22"
Vk_20240820_25,2024-08-27,2025-03-11,"New Field Safety Notice","Instrumentation Laboratory Co.","HemosIL AcuStar ADAMTS 13","IVD: Coagulation Factors - Other","0009802048; 0009802048","All in date",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240820_25"
Vk_20250227_27,2025-03-04,2025-03-11,"Added new language","Medtronic Inc.","MyPTM App","MD: Implantable Pumps Programmers - Medical Device Software",A820,,All,2.X,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250227_27"
Vk_20241029_02,2024-11-05,2025-03-10,,"Bard Access Systems Inc",PowerPICC,"MD: Peripherally-inserted central venous catheter","see FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241029_02"
Vk_20250214_01,2025-02-19,2025-03-07,"Added new language","Waldemar Link GmbH & Co. KG","Modular Stem cylindrical, press-fit cementless","MD: Knee tibia stem prosthesis","880-601/11, 880-601/12, 880-601/13","see FSN",,N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250214_01"
Vk_20240909_01,2024-09-11,2025-03-07,"Updated FSN","iSTAR Medical SA","MINIject S","MD: Glaucoma supraciliary implant","FG2001ZA; FG2001ZB",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240909_01"
Vk_20250225_01,2025-02-25,2025-03-06,"Added new language","DePuy MITEK Inc.","COR Disposable Kit, 8mm and 8mm w/Perpendicularity","MD: General internal orthopaedic fixation system implantation kit",252112,23D14,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250225_01"
Vk_20250218_21,2025-03-06,2025-03-06,,EPPUR,DREEFT,"MD: wheelchair","0176, 0369",,"All serial number",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250218_21"
Vk_20250226_16,2025-03-05,2025-03-05,,"LTA MEDICAL","Single use endoscope cleaning brush","MD: Surgical instrument/endoscope cleaning utensil, single-use",100-1824/50S,24490097,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250226_16"
Vk_20250226_06,2025-03-04,2025-03-04,,"DH Healthcare GmbH","ORBIS Medication 3.x","MD: General Medicine Instruments - Other",,,,03.20.00.00,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250226_06"
Vk_20250227_32,2025-03-04,2025-03-04,,"DH Healthcare GmbH","ORBIS Medication 3.x","MD: General Medicine Instruments - Other",,,,03.16.00.00,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250227_32"
Vk_20250228_38,2025-03-04,2025-03-04,,"DH Healthcare GmbH","DeepUnity Diagnost","MD: Picture Archiving And Communication Systems",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250228_38"
Vk_20250226_15,2025-03-04,2025-03-04,,"Fujifilm Corporation","DR-XD 1000 / FDR Nano","MD: Various Instruments For Radiodiagnostics And Interventional Procedures",,,"#xxxx2153 or earlier",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250226_15"
Vk_20250224_21,2025-02-26,2025-02-26,,"Beckman Coulter , Inc.","DxC 500 AU Clinical Chemistry Analyzer","IVD: Multiple clinical chemistry analyser IVD, laboratory","C63519, C63520",,"Please refer to Appendix A in the FSN 25007 letter","V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3","https://fsca.swissmedic.ch/mep/#?q=Vk_20250224_21"
Vk_20250219_01,2025-02-26,2025-02-26,,"Beckman Coulter , Inc.","DxI 9000 Access Immunoassay Analyzer","IVD: Chemiluminescent immunoassay analyser IVD","see FSN",,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250219_01"
Vk_20241024_01,2024-10-30,2025-02-26,"additional information","Baxter Healthcare SA","MINICAP EXTEND LIFE PD TRANSFER SET","MD: Peritoneal dialysis system tubing set","R5C4482, R5C4484","All lots within expiry",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241024_01"
Vk_20250219_03,2025-02-26,2025-02-26,,"Beckman Coulter Inc.","DxI 9000 Access Immunoassay Analyzer","IVD: Chemiluminescent immunoassay analyser IVD","See FSN",,"See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250219_03"
Vk_20250224_22,2025-02-25,2025-02-25,,"ICU Medical Incformerly Smiths Medical ASD","BCI Airway Adapters","MD: Capnography sampling adaptor","WW1100, WW8214","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250224_22"
Vk_20250219_02,2025-02-25,2025-02-25,,"US Endodontics, LLC","Edge Endodontic Rotary Files","MD: Endodontic Instruments (canal Enlargers, Files, Rasps, Etc.), Single-use","See FSN","See FSN","See FSN","Not Applicable","https://fsca.swissmedic.ch/mep/#?q=Vk_20250219_02"
Vk_20250221_24,2025-02-25,2025-02-25,,"DH Healthcare GmbH","DeepUnity Viewer 2.x","MD: Picture Archiving And Communication Systems",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250221_24"
Vk_20250219_20,2025-02-25,2025-02-25,,"Covidien LLC","Microstream Advance Neonatal-Infant and Adult-Pediatric Intubated CO2 Filter Line; Microstream Luer Adult-Pediatric Intubated CO2 Filter Line; Microstream Luer Adult-Pediatric Airway Adapter Sampling Line","MD: RESPIRATORY AND ANAESTHESIA DEVICES - OTHERS; RESPIRATORY AND ANAESTHESIA DEVICES: OXYGEN ADMINISTRATION TUBINGS","See FSN",All,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250219_20"
Vk_20250214_22,2025-02-21,2025-02-21,,"Philips Medical Systems","IntelliSpace Cardiovascular","MD: Radiology picture archiving and communication system workstation",830089,,,7.0.0.0,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250214_22"
Vk_20250212_02,2025-02-20,2025-02-20,,"Beckman Coulter Inc.","Access 2 Immunoassay Analyzer","IVD: Chemiluminescent immunoassay analyser IVD",81600N,,"Refer to appendix A for the list of impacted in the FSN 25003 letter.",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250212_02"
Vk_20250204_02,2025-02-20,2025-02-20,,"Abbott Medical",Endurity,"AIMD: Single-chamber implantable pacemaker, rate-responsive","PM1140, PM1152, PM1160, PM1162, PM1172, PM2140, PM2152, PM2162, PM2172",,"see FSN, devices manufactured between August 2019 and June 2020",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250204_02"
Vk_20250204_02,2025-02-20,2025-02-20,,"Abbott Medical",Assurity,"AIMD: Dual-chamber implantable pacemaker, rate-responsive","PM1272, PM2240, PM2272",,"see FSN, devices manufactured between August 2019 and June 2020",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250204_02"
Vk_20241227_26,2024-12-27,2025-02-20,"Added new language","Instrumentation Laboratory Co.","HemosIL Heparin Calibrators","IVD: Heparin anti-Xa IVD, calibrator",0020300600,"N0128933, N0220450, N0522479, N0724070, N1026509, N0239584, N0531891, N0733658, N0249207, N0442161, N0744673",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241227_26"
Vk_20250214_26,2025-02-19,2025-02-19,,"Aesculap AG","ORTHOPILOT, ORTHOPILOT CAP EINMAL-MARKER","MD: Robotic surgical navigation system",FS618SU,"siehe FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250214_26"
Vk_20250217_12,2025-02-18,2025-02-18,,"Siemens Healthcare Diagnostics Manufacturing Limited","Atellica CH Diluent","IVD: Buffered sample diluent IVD",11099300,0000191602,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250217_12"
Vk_20250214_16,2025-02-18,2025-02-18,,"ICU Medical","Intubation ORAL/NASAL Endotracheal Tube","MD: Basic endotracheal tube, single-use","See FSN","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250214_16"
Vk_20250218_01,2025-02-18,2025-02-18,,"Intersurgical Ltd","Various Uniflow Coaxial Breathing Systems","MD: Ventilator breathing circuit, single-use",2900000,"See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250218_01"
Vk_20250212_08,2025-02-18,2025-02-18,,"Medline International France SAS","Caresets and Sterile Procedure Trays","MD: General surgical procedure kit, non-medicated, single-use","See FSN","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250212_08"
Vk_20250204_22,2025-02-17,2025-02-17,,"Chromsystems Instruments & Chemicals GmbH","MassTox Antimycotic Drugs/EXTENDED Cali/Con","IVD: Multiple antifungal therapeutic drug monitoring IVD, calibrator","92051/XT, 0253/XT, 0254/XT","#4922, #1624",n/a,n/a,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250204_22"
Vk_20250212_25,2025-02-17,2025-02-17,,"Applimed SA","childbirth set","MD: Kit, surgical - general",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250212_25"
Vk_20250212_25,2025-02-17,2025-02-17,,"Applimed SA","Ablation Suture Set","MD: Kit, surgical - general","See FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250212_25"
Vk_20250212_25,2025-02-17,2025-02-17,,"Applimed SA","Care Set","MD: Kit, surgical - general","See FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250212_25"
Vk_20250212_25,2025-02-17,2025-02-17,,"Applimed SA",Forceps,"MD: Dressing forceps","See FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250212_25"
Vk_20240130_37,2024-01-31,2025-02-17,"Additional languages for version 3, correction for devices on Swiss market (DE-3, FR-3, IT-3)","BioFire Diagnostics, LLC","BioFire FilmArray Pneumonia plus (PN plus) Panel","IVD: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)","RFIT-ASY-0143 (Pnplus, 30-pack)","All unexpired lots",,"v2.0 - v2.1.0.5","https://fsca.swissmedic.ch/mep/#?q=Vk_20240130_37"
Vk_20250129_14,2025-02-10,2025-02-14,"Updated information","Medtronic (Schweiz) AG","MiniMed 670G Insulin Pump","MD: Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm","MMT-1761, MMT-1762, MMT-1781, MMT-1782",,all,n/a,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250129_14"
Vk_20250129_14,2025-02-10,2025-02-14,"Updated information","Medtronic (Schweiz) AG","MiniMed 770G Insulin Pump","MD: Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm","MMT-1881, MMT-1882, MMT-1891, MMT-1892",,all,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250129_14"
Vk_20250129_14,2025-02-10,2025-02-14,"Updated information","Medtronic (Schweiz) AG","MiniMed 720G Insulin Pump","MD: Ambulatory insulin infusion pump, electronic, non-software-dosing","MMT-1809, MMT-1810, MMT-1859, MMT-1860",,all,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250129_14"
Vk_20250129_14,2025-02-10,2025-02-14,"Updated information","Medtronic (Schweiz) AG","MiniMed 640G Insulin Pump","MD: Ambulatory insulin infusion pump, electronic, software-dosing, binary algorithm","MMT-1711, MMT-1712, MMT-1751, MMT-1752",,all,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250129_14"
Vk_20250129_14,2025-02-10,2025-02-14,"Updated information","Medtronic (Schweiz) AG","MiniMed 740G Insulin Pump","MD: Ambulatory insulin infusion pump, electronic, software-dosing, binary algorithm","MMT-1811, MMT-1812, MMT-1861, MMT-1862",,all,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250129_14"
Vk_20250129_14,2025-02-10,2025-02-14,"Updated information","Medtronic (Schweiz) AG","MiniMed 780G Insulin Pump","MD: Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm","MMT-1885, MMT-1886, MMT-1895, MMT-1896",,all,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250129_14"
Vk_20250129_14,2025-02-10,2025-02-14,"Updated information","Medtronic (Schweiz) AG","MiniMed Paradigm Veo","MD: Ambulatory insulin infusion pump, electronic, software-dosing, binary algorithm","MMT-554, MMT-715, MMT-722, MMT-754",,all,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250129_14"
Vk_20250129_14,2025-02-10,2025-02-14,"Updated information","Medtronic (Schweiz) AG","MiniMed Paradigm Insulin Pump","MD: Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm","MMT-554, MMT-715, MMT-722, MMT-754",,all,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250129_14"
Vk_20250117_15,2025-02-14,2025-02-14,,"DIETZ GmbH","TSE 2.0-SC","MD: medical toilet seat",429100,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250117_15"
Vk_20250117_15,2025-02-14,2025-02-14,,"DIETZ GmbH",SmartFix,"MD: medical toilet seat",429112,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250117_15"
Vk_20240620_03,2025-02-13,2025-02-13,,"Maquet Cardiovascular, LLC","VASOVIEW HEMOPRO, VASOVIEW HEMOPRO 2","MD: Flexible endoscopic scissors, reusable"," VH-4000","All Lots",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240620_03"
Vk_20250210_32,2025-02-12,2025-02-12,,"Balt Extrusion",HYBRID,"MD: Cardiac/peripheral vascular guidewire, single-use",HYBRID007D.120,00567735,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250210_32"
Vk_20250207_18,2025-02-12,2025-02-12,,"Ortho-Clinical Diagnostics","ORTHO Optix Reader BioVue","IVD: Agglutination assay digital imaging reader/analyser IVD",6842223,,,"Version 2.0.0 and Version 2.0.1","https://fsca.swissmedic.ch/mep/#?q=Vk_20250207_18"
Vk_20250210_03,2025-02-11,2025-02-12,"Added new language","PMH - PRODUTOS MEDICOS HOSPITALARES","Edelvaiss 10.3 VD","MD: Basic intravenous administration set, noninvasive",103.0070,"32 24 10 P",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250210_03"
Vk_20250207_33,2025-02-11,2025-02-11,,"DH Healthcare GmbH","ORBIS Medication 3.x","MD: General Medicine Instruments - Other",,,,03.16.00.00,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250207_33"
Vk_20250205_01,2025-02-11,2025-02-11,,"Leica Biosystems Melbourne Pty Ltd",BOND-PRIME,"IVD: Microscope slide stainer IVD","091.0021; 091.0021",,"see FSN",N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250205_01"
Vk_20250205_18,2025-02-11,2025-02-11,,"Brainlab AG","Multidisciplinary medical image management software","MD: Multidisciplinary medical image management software","see FSN",,,"ODM v. 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1","https://fsca.swissmedic.ch/mep/#?q=Vk_20250205_18"
Vk_20250131_09,2025-02-11,2025-02-11,,"Fresenius Kabi AG","Exelia SP","MD: Bedside syringe pump",Z084010,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250131_09"
Vk_20250131_09,2025-02-11,2025-02-11,,"Fresenius Kabi AG","Exelia VP","MD: Bedside infusion pump, single-channel",Z085010,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250131_09"
Vk_20250131_09,2025-02-11,2025-02-11,,"Fresenius Kabi AG","Exelia Combox","MD: Bedside syringe pump",Z086710,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250131_09"
Vk_20250131_09,2025-02-11,2025-02-11,,"Fresenius Kabi AG","Exelia Therapy Manager","MD: Bedside syringe pump",Z086810,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250131_09"
Vk_20250127_01,2025-02-10,2025-02-10,,"Spacelabs Healthcare Inc.","Xhibit Telemetry Receiver (XTR)","MD: Electrocardiography monitoring system receiver",96280,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250127_01"
Vk_20240206_14,2024-02-13,2025-02-10,"Information added regarding previously generated patient results","BioFire Diagnostics, LLC","FilmArray Gastrointestinal (GI) Panel","IVD: Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)","RFIT-ASY-0116; RFIT-ASY-0104; RFIT-ASY-0116; RFIT-ASY-0104","All lot numbers, All unexpired product",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240206_14"
Vk_20250127_26,2025-02-10,2025-02-10,,"SPINEART SA","secured lumbar anterior cages SCARLET AL-T","MD: Metallic spinal interbody fusion cage","see FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250127_26"
Vk_20250131_23,2025-02-04,2025-02-07,"Added new language","DH Healthcare GmbH","DeepUnity PACSonWEB","MD: Picture Archiving And Communication Systems",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250131_23"
Vk_20241213_28,2024-12-20,2025-02-06,"Added new language","Maquet Critical Care AB","Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e","MD: Anaesthesia workstation, general-purpose","6682285 Vaporizer Sevoflurane QuikFil used with Flow-i: C20 6677200, 688852, C30 6677300, 6888530, C40 6677400, 6888540, Flow-c: 6887700, Flow-e: 6887900",,"See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241213_28"
Vk_20250127_38,2025-02-06,2025-02-06,,"Aesculap AG","Sterilisation container","MD: Device sterilization/disinfection container, reusable","See FSN","See FSN","See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250127_38"
Vk_20250205_21,2025-02-05,2025-02-05,,"Medtronic Inc.","Aortic Root Cannula","MD: Cardioplegia cannula","CFN 11014","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250205_21"
Vk_20250205_21,2025-02-05,2025-02-05,,"Medtronic Inc.","MiAR Cannulae","MD: Cardioplegia cannula","CFR 11012L; CFN 11014L","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250205_21"
Vk_20250130_02,2025-02-04,2025-02-04,,"Ovesco Endoscopy","Colonic FTRD Set","MD: Endoscopic electrosurgical full-thickness tissue biopsy/resection set",200.70,856866,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250130_02"
Vk_20250130_01,2025-02-04,2025-02-04,,"Biomet UK Ltd","G7 Acetabular System - Bispherical Cup","MD: Acetabular shell","see FSN",all,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250130_01"
Vk_20250123_24,2025-02-04,2025-02-04,,"Wright Medical Technology, Inc.","ORTHOLOC 3DI Drill Bit","MD: Fluted surgical drill bit, single-use","588S50025, 588S80020","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250123_24"
Vk_20250123_24,2025-02-04,2025-02-04,,"Wright Medical Technology, Inc.","CHARLOTTE Compression Staple","MD: Orthopaedic bone staple, non-adjustable","43110009, 43S10001","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250123_24"
Vk_20250123_24,2025-02-04,2025-02-04,,"Wright Medical Technology, Inc.","AEQUALIS REVERSED FRACTURE Adaptor","MD: Total reverse shoulder prosthesis",DWD922,"see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250123_24"
Vk_20250123_24,2025-02-04,2025-02-04,,"Wright Medical Technology, Inc.","CHARLOTTE Screwdriver","MD: Orthopaedic implant driver",45112000,"see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250123_24"
Vk_20250123_24,2025-02-04,2025-02-04,,"Wright Medical Technology, Inc.","CHARLOTTE Snap-Off Screw","MD: Orthopaedic bone screw, non-bioabsorbable, sterile","45S10001, 45S10002, 45S10003","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250123_24"
Vk_20250123_24,2025-02-04,2025-02-04,,"Wright Medical Technology, Inc.","DART-FIRE Washer","MD: Implantable bone washer",5881003540,"see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250123_24"
Vk_20250123_24,2025-02-04,2025-02-04,,"Wright Medical Technology, Inc.","ORTHOLOC 3DI Cancellous Screw","MD: Orthopaedic bone screw (non-sliding)",58934040,"see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250123_24"
Vk_20250123_24,2025-02-04,2025-02-04,,"Wright Medical Technology, Inc.","ORTHOLOC 3DI Cortical Screw","MD: Orthopaedic bone screw (non-sliding)","58913512, 58913514, 58913516, 58913518, 58913520, 58913522, 58913526, 58913538, 58913542, 58913544, 58913555","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250123_24"
Vk_20250123_24,2025-02-04,2025-02-04,,"Wright Medical Technology, Inc.","ORTHOLOC 3Di Cutting Guide","MD: Osteotomy guide, reusable",58190018,"see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250123_24"
Vk_20250123_24,2025-02-04,2025-02-04,,"Wright Medical Technology, Inc.","ORTHOLOC 3Di Displacement Inserter","MD: Orthopaedic inorganic implant inserter/extractor, reusable",58190016,"see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250123_24"
Vk_20250123_24,2025-02-04,2025-02-04,,"Wright Medical Technology, Inc.","ORTHOLOC 3DI Temp Fixation Pin","MD: Orthopaedic bone wire","58820024, 588S20024",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250123_24"
Vk_20250123_24,2025-02-04,2025-02-04,,"Wright Medical Technology, Inc.","ORTHOLOC Less Met T Plate","MD: Orthopaedic fixation plate, non-bioabsorbable, non-sterile",5201000204,"see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250123_24"
Vk_20250123_24,2025-02-04,2025-02-04,,"Wright Medical Technology, Inc.","PRO-TOE VO Implant","MD: Orthopaedic bone screw, non-bioabsorbable, sterile",45712410,"see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250123_24"
Vk_20250123_24,2025-02-04,2025-02-04,,"Wright Medical Technology, Inc.","SWANSON/HUNTER Flexspan Tendon Spacer","MD: Tendon sheath regeneration implant","24270003, 24270004, 24270005, 24270006","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250123_24"
Vk_20250122_05,2025-02-04,2025-02-04,,"LivaNova USA, Inc.","SenTiva VNS Therapy Generator","AIMD: Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system","Model 1000; Model 1000-D; Model 1000C (investigational use)",,"All serial numbers produced",N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250122_05"
Vk_20250130_37,2025-02-04,2025-02-04,,"CompuGroup Medical Software GmbH","CGM CLINICAL Medication","MD: Medical Device Software - Not Included In Other Classes",,,,9.1,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250130_37"
Vk_20240408_29,2024-04-09,2025-02-03,,"Philips Medical Systems","Electric power supply","MD: Basic power supply, reusable","120V -SCL500RM1U, 230V -SCL500RMI1U",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240408_29"
Vk_20250131_26,2025-02-03,2025-02-03,,"Hamilton Medical AG","In2Flow Nasal cannula","MD: Air/oxygen Masks And Nasal Cannulas","10076606, 10076605, 10076604","Lot numbers with production date after 31.12.2022",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250131_26"
Vk_20240606_13,2024-06-11,2025-02-03,,"Philips Healthcare Enterprise Imaging Informatics","SENSE XL Torso coil (1.5T and 3.0T)","MD: Full-body MRI system, superconducting magnet","453567141882, 453567141883, 989603014351, 989603014352, ",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240606_13"
Vk_20250115_05,2025-01-31,2025-01-31,,"DH Healthcare GmbH","DeepUnity Viewer 2.x","MD: Picture Archiving And Communication Systems",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250115_05"
Vk_20250130_24,2025-01-30,2025-01-30,,"Micro Therapeutics Inc, d/b/a Ev3 Neurovascular","Pipeline Vantage Embolization Device with Shield T","MD: Bare-metal intracranial vascular stent","PED3-027-XXX-XX; PED3-021-XXX-XX","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250130_24"
Vk_20240829_15,2025-01-30,2025-01-30,,"Datex-Ohmeda Inc.","Giraffe and Panda","MD: Heater",,,"Devices manufactured between 18 Aug 2023 to 20 Jun 2024",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240829_15"
Vk_20250117_12,2025-01-29,2025-01-29,,"Philips Medizinsysteme Böblingen GmbH","IntelliBridge EC10 Module","MD: Patient monitoring system module, interfacing","865115, 866060, 866062, 866064, 866066",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250117_12"
Vk_20250123_21,2025-01-29,2025-01-29,,"MAQUET Cardiopulmonary GmbH","Heater-Cooler Unit HCU 40 High Voltage","MD: Cardiopulmonary bypass system heat exchanger, reusable","701044054, 701054917",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250123_21"
Vk_20250127_02,2025-01-29,2025-01-29,,"Percussionaire Corporation","Phasitron Kit, VDR, Single Patient","MD: Ventilator breathing circuit, single-use",A50094-D-5PK,"See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250127_02"
Vk_20250124_02,2025-01-28,2025-01-28,,"Spectrum Medical Europe srl","Quantum Perfusion Centrifugal Blood Pump","MD: Cardiopulmonary bypass system centrifugal pump",CP22V-VPL,G001602,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250124_02"
Vk_20250127_41,2025-01-28,2025-01-28,,"Leica Biosystems Nussloch GmbH","Leica CM1950","IVD: Cryostat microtome IVD","1491950C2EU, 1491950C3EU, 1491950C5EU",,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250127_41"
Vk_20250121_12,2025-01-27,2025-01-27,,"LivaNova USA, Inc.","SenTiva VNS Therapy Generator","AIMD: Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system","Model 1000, Model 1000-D",,"Refer to attachment 1.",N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250121_12"
Vk_20250115_01,2025-01-27,2025-01-27,,"Illumina, Inc","NovaSeq 6000Dx","IVD: Nucleic acid sequence analyser IVD, next-generation sequencing (NGS)",20068232,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250115_01"
Vk_20241202_12,2024-12-17,2025-01-27,"added customer feedback form","Physiomed Elektromedizin AG","Compass MTT Rückentrainer Kombi","MD: Exercisers, Back",10113700,,"10113700.21.0453.00.00 bis 10113700.24.02228.00",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241202_12"
Vk_20250127_37,2025-01-27,2025-01-27,,"Medartis AG","2.0/2.3 TriLock Plate MC I Base, t1.0","MD: Bone Fixation Plates","A-4650; A-4650.90S",24390415,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250127_37"
Vk_20250115_03,2025-01-27,2025-01-27,,"DH Healthcare GmbH","DeepUnity Viewer 2.x","MD: Picture Archiving And Communication Systems",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250115_03"
Vk_20250114_11,2025-01-24,2025-01-24,,"Medimaps Group SA","TBS iNsight / TBS Osteo","MD: Bone Densitometry Systems - Medical Device Software",,,,V3.x,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250114_11"
Vk_20250120_01,2025-01-24,2025-01-24,,"RaySearch Laboratories AB",RayStation,"MD: Various Radiotherapy And Radiosurgery Instruments - Software Accessories","4.5 to 2024B including some service packs",,"See FSN","RayStation 4.5 to 2024B","https://fsca.swissmedic.ch/mep/#?q=Vk_20250120_01"
Vk_20220331_16,2022-04-05,2025-01-23,"distributing clinician tablet, model CT900F, and a software update for the clinician programmer application A610 version 5.0 or later","Medtronic Inc.","Percept PC BrainSense","AIMD: Deep brain electrical stimulation system",B35200,,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20220331_16"
Vk_20240515_33,2024-05-21,2025-01-23,"distributing clinician tablet, model CT900F, and a software update for the clinician programmer application A610 version 5.0 or later","Medtronic Inc.",Percept,"AIMD: Deep brain electrical stimulation system","impacts patients who have a pocket adaptor with Percept PC B35200, or Percept RC B35300 that previously used the A610 REPLACEMENT workflow to transfer settings from Activa SC Model 37602.",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240515_33"
Vk_20240515_33,2024-05-21,2025-01-23,"distributing clinician tablet, model CT900F, and a software update for the clinician programmer application A610 version 5.0 or later","Medtronic Inc.","Activa SC","AIMD: Deep brain electrical stimulation system","impacts patients who currently have an Activa SC Model 37602 implanted and are implanted with a pocket adaptor in the future during an INS replacement, with settings transferred using the A610 REPLACEMENT workflow.",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240515_33"
Vk_20240515_33,2024-05-21,2025-01-23,"distributing clinician tablet, model CT900F, and a software update for the clinician programmer application A610 version 5.0 or later","Medtronic Inc.","DBS Clinician Programmer Application","MD: Clinician Programmer Software Application",A610,,,"Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605, 2.0.4630, and 2.0.4648); Version 3.0.x (3.0.1057, 3.0.1062, 3.0.1081, and 3.0.1098); Version 4.0.x (4.0.1052)","https://fsca.swissmedic.ch/mep/#?q=Vk_20240515_33"
Vk_20240515_33,2024-05-21,2025-01-23,"distributing clinician tablet, model CT900F, and a software update for the clinician programmer application A610 version 5.0 or later","Medtronic Inc.","DBS Pocket Adaptor","AIMD: Neural-tissue electrical stimulation lead adaptor","64001 or 64002",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240515_33"
Vk_20240515_33,2024-05-21,2025-01-23,"distributing clinician tablet, model CT900F, and a software update for the clinician programmer application A610 version 5.0 or later","Medtronic Inc.","Activa SC","AIMD: Deep brain electrical stimulation system","impacts patients who have a pocket adaptor with Activa SC Model 37603, that previously used the A610 REPLACEMENT workflow to transfer settings from Activa SC Model 37602.",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240515_33"
Vk_20211013_07,2021-10-19,2025-01-23,"distributing clinician tablet, model CT900F, and a software update for the clinician programmer application A610 version 5.0 or later","Medtronic Inc.","Percept PC BrainSense","AIMD: Deep brain electrical stimulation system",B35200,,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20211013_07"
Vk_20250116_21,2025-01-23,2025-01-23,,"Philips Medical Systems Nederland B.V.","Philips Allura and Azurion","MD: Stationary general-purpose fluoroscopic x-ray system, analogue","see FSN",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250116_21"
Vk_20250120_13,2025-01-22,2025-01-22,,"ICU Medical, Inc.","Plum 360 infusion systems","MD: Bedside infusion pump, single-channel","See FSN","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250120_13"
Vk_20250108_01,2025-01-22,2025-01-22,,"Belmont Medical Technologies","3 Spike Disposable Set","MD: Heat-exchanging intravenous administration set","903-00006; 903-00006","20241006, 20241014",N/A,N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250108_01"
Vk_20230523_20,2023-05-30,2025-01-22,,"Drägerwerk AG & Co. KGaA","Oxylog 3000 plus","MD: Ventilators, Transport","5704811 and 5704813",,All,n/a,"https://fsca.swissmedic.ch/mep/#?q=Vk_20230523_20"
Vk_20250116_01,2025-01-21,2025-01-21,,"Philips Medical Systems Nederland B.V.","Philips Allura and Azurion","MD: Stationary general-purpose fluoroscopic x-ray system, analogue","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250116_01"
Vk_20241218_22,2024-12-20,2025-01-21,"Added new language","Olympus Medical Systems Corp.","Forceps/Irrigation Plug (Isolated Type)","MD: Endoscope working-channel valve, reusable","MAJ-891 / N6149350",All,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241218_22"
Vk_20250117_01,2025-01-21,2025-01-21,,"HOYA Corp.","PENTAX Medical Video Processor","MD: Endoscopic video image processing unit",EPK-i8020c,,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250117_01"
Vk_20250117_01,2025-01-21,2025-01-21,,"HOYA Corp.","PENTAX Medical Video Colonoscope","MD: Flexible video colonoscope, reusable","EC34-i20cL, EC34-i20cF, EC34-i20cM, EC38-i20cL, EC38-i20cF, EC38-i20cM",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250117_01"
Vk_20250117_01,2025-01-21,2025-01-21,,"HOYA Corp.","PENTAX Medical Video Upper GI Scope","MD: Flexible video gastroscope, reusable","EG27-i20c, EG29-i20c",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250117_01"
Vk_20250116_20,2025-01-21,2025-01-21,,"Olympus Medical Systems Corp.","Single use guide sheath kit","MD: Flexible endoscopic biopsy forceps, single-use","K-201, K-202, K-203, K-204; N3041830, N3041930, N3042030, N3042130","All (within shelf life)",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250116_20"
Vk_20250116_13,2025-01-21,2025-01-21,,Landanger,"LANDANGER - DISPOSABLE INSUFFLATION NEEDLE","MD: Veress Needles",E201152,2326454,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250116_13"
Vk_20220331_20,2022-04-05,2025-01-21,"Information concerning the possible recurrence of the issue","Medtronic Inc.","Vanta with AdaptiveStim Technology Primary cell neurostimulator","AIMD: Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable",977006,,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20220331_20"
Vk_20250117_04,2025-01-21,2025-01-21,,"Biomet France","Optipac Vacuum mixing system","MD: Orthopaedic cement, antimicrobial","See FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250117_04"
Vk_20250120_22,2025-01-21,2025-01-21,,"Carl Zeiss Meditec AG","AT TORBI 719MP","MD: Posterior-chamber intraocular lens, pseudophakic",,,"1S232200E137 , AT TORBI 719MP SE+17.00 CYL02.5",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250120_22"
Vk_20240424_27,2024-05-01,2025-01-20,"add. languages: scope extended & new info; FSN A for customers of FSN1, FSN B for newly affected customers, FSN C for newly delivered devices","Maquet Critical Care AB","Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e","MD: Anaesthesia workstation, general-purpose","6888520, 6888530, 6888540, 6887700, 6887900",,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240424_27"
Vk_20241213_27,2024-12-20,2025-01-17,"update FSN","Becton, Dickinson and Company","BD PCR Cartridge","IVD: Thermal cycler nucleic acid amplification analyser IVD, laboratory",437519,"see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241213_27"
Vk_20240424_19,2024-04-30,2025-01-16,,"Dong Guan QueenMed Equipment Mfg Co Ltd","Electrosurgical Electrode","MD: Open-surgery electrosurgical handpiece/electrode, monopolar, single-use","See FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240424_19"
Vk_20250108_11,2025-01-15,2025-01-15,,"HeartWare Inc.","HeartWare Monitor","AIMD: Implantable ventricular circulatory assist system",1521XX-Y,,all,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250108_11"
Vk_20250114_02,2025-01-14,2025-01-14,,"Intact Vascular, Inc.","Tack Endovascular System","MD: Peripheral artery stent, bare-metal","see FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250114_02"
Vk_20250110_02,2025-01-14,2025-01-14,,"Soluscope SAS","SOLUSCOPE SERIE 4 PA","MD: Flexible endoscope washer","SL-V4-PA; SL-V4-SA-PA; SL-V4-RO-PA",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250110_02"
Vk_20241223_03,2025-01-13,2025-01-13,,"Aesculap AG","HAEMOSTATIC FORCEPS / CLAMPS","MD: Surgical soft-tissue manipulation forceps, scissors-like, reusable","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241223_03"
Vk_20241021_02,2024-10-28,2025-01-13,"newly implemented bug fix","Roche Diabetes Care GmbH","Accu-Chek Care","MD: General Medicine Diagnosis And Monitoring Instruments - Medical Device Software","1009594600, device identifier: 04015630088928",,,"1.0.2, 1.0.4","https://fsca.swissmedic.ch/mep/#?q=Vk_20241021_02"
Vk_20250107_08,2025-01-10,2025-01-10,,"EON MEDITECH PVT. LTD","Saugkanüle gebogen","MD: Suction tube","96-FI1230125, 96-FI1230140, 96-FI1230160, 96-FI1240140, 96-FI1240160","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250107_08"
Vk_20241219_01,2024-12-19,2025-01-10,"Added new language","Nobel Biocare AB","Nobel Biocare N1 TiUltra TCC","MD: Dental Implants","see FSN","see FSN",,N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241219_01"
Vk_20241223_26,2025-01-09,2025-01-09,,"Intuitive Surgical, Inc","Da Vinci X / Xi Surgical System","MD: Robotic surgical arm system","See FSN","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241223_26"
Vk_20241223_27,2025-01-08,2025-01-09,"Added new language","Intuitive Surgical, Inc","EndoWrist Small Grasping Retractor","MD: Robotic surgical retractor",470318,"All lots",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241223_27"
Vk_20241223_27,2025-01-08,2025-01-09,"Added new language","Intuitive Surgical, Inc","EndoWrist Tenaculum Forceps","MD: Robotic surgical forceps, reusable",470207,"All lots",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241223_27"
Vk_20240926_35,2024-10-23,2025-01-09,,"Venclose,  Inc.","Venclose EVSRF Catheter","MD: Peripheral vascular electrocautery catheter, single-use","VCOUS6F60, VCOUS6F100","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240926_35"
Vk_20241204_48,2024-12-11,2025-01-08,,"Accuray Incorporated",Cyberknife,"MD: Single Energy Linear Accelerators","All CyberKnife using Standard Treatment Couch",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241204_48"
Vk_20241113_01,2024-11-19,2025-01-07,,"Philips Medical Systems Nederland B.V.","Philips Allura Xper","MD: Stationary general-purpose fluoroscopic x-ray system, analogue","see FSN",,,"R 7.6 - R 8.1","https://fsca.swissmedic.ch/mep/#?q=Vk_20241113_01"
Vk_20241218_25,2025-01-06,2025-01-06,,"Occlutech GmbH","Figulla Flex II ASD Occluder","MD: Cardiac defect occluder","29ASD09F, 29ASD09P, 29ASD09FC, 29ASD09PC, 29ASD10F, 29ASD10P, 29ASD10FC, 29ASD10PC","See FSN","See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241218_25"
Vk_20250103_15,2025-01-03,2025-01-03,,"Spacelabs Healthcare Ltd","Eclipse Pro and Eclipse Mini","MD: Electrocardiographic ambulatory recorder","98700 and 98900",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250103_15"
Vk_20241227_02,2024-12-30,2024-12-30,,bioMérieux,"VIDAS CK-MB","IVD: Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)",30421,"1010844200, 1010959330, 1010987820",N/A,N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241227_02"
Vk_20241227_35,2024-12-27,2024-12-27,,"Draeger Medical Systems, Inc.","Edifier Lautsprecher","MD: Centralized patient monitor",MS34036,"See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241227_35"
Vk_20241227_35,2024-12-27,2024-12-27,,"Draeger Medical Systems, Inc.","Infinity Central Station","MD: Centralized patient monitor",MS26800,,,VG3.0,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241227_35"
Vk_20241227_42,2024-12-27,2024-12-27,,"Löwenstein Medical Innovation GmbH & Co. KG",elisa,"MD: Intensive care ventilator","elisa 300, elisa 500, elisa 600, elisa 800, elisa 800VIT",,,2.13.6,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241227_42"
Vk_20241216_02,2024-12-27,2024-12-27,,"Mercury Medical","T-Piece Resuscitator","MD: Manually Operated Pulmonary Resuscitators","1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050841, 1050842","See FSN","See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241216_02"
Vk_20241118_13,2024-12-27,2024-12-27,,"Philips Electronics Nederland B.V.","Spectral CT/Spectral CT Plus","MD: EMDN=37618","728333, 728340, 728344",,"10042, 10065, 10075, 10077, 10120, 10143, 10156, 10247",5.0.X,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241118_13"
Vk_20241227_01,2024-12-27,2024-12-27,,"QuidelOrtho (Ortho-Clinical Diagnostics Inc.)","VITROS XT7600","IVD: Multiple clinical chemistry analyser IVD, laboratory",6844461,,"76000375, 76000852","3.8.0 and above","https://fsca.swissmedic.ch/mep/#?q=Vk_20241227_01"
Vk_20241204_22,2024-12-23,2024-12-23,,"Medicrea International"," UNiD Adaptive Spine Intelligence (ASI)","MD: Orthopaedic/craniofacial implantation planning software",,,," UNiD HUB version 4.2.0, UNiD Spine Analyzer version 4.1","https://fsca.swissmedic.ch/mep/#?q=Vk_20241204_22"
Vk_20241220_25,2024-12-23,2024-12-23,,"Ethicon, LLC","ETHILON Nylon Suture","MD: Nylon suture, non-bioabsorbable, monofilament","F2416H, 661H","103E7C, 103H5A",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241220_25"
Vk_20241220_25,2024-12-23,2024-12-23,,"Ethicon, LLC","ETHIBOND EXCEL Polyester Suture","MD: Polyester suture, non-bioabsorbable, multifilament","6664H, EH7491H","103G1B, 103D42",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241220_25"
Vk_20241223_33,2024-12-23,2024-12-23,,"Diametros Medical S.r.l.","Lobster Project 2.0 implantable device","MD: Lumbar interspinous decompression spacer","see FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241223_33"
Vk_20241223_01,2024-12-23,2024-12-23,,"Boston Scientific Corporation","AXIOS Stent and Electrocautery - Enhanced Delivery System","MD: Implantable transenteric drainage tube","See FSN","See FSN","See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241223_01"
Vk_20241121_15,2024-11-29,2024-12-20,"add. Action to be taken described","Edwards Lifesciences LLC","EZ Glide Aortic Cannula","MD: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return","see FSN","see FSN",N/A,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241121_15"
Vk_20241219_20,2024-12-20,2024-12-20,,"Mint Medical GmbH","Mint Lesion","MD: Radiology Instruments - Software Accessories",,,,"3.9.0, 3.9.1, 3.9.2, 3.9.3, 3.9.4, 3.9.5, 3.10.0 and 3.10.1","https://fsca.swissmedic.ch/mep/#?q=Vk_20241219_20"
Vk_20241212_27,2024-12-20,2024-12-20,,"Spiegelberg GmbH & Co. KG","Probe 3","MD: Intracerebral infusion/drainage catheter, short-term",SND13.1.13,,32034,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241212_27"
Vk_20241212_27,2024-12-20,2024-12-20,,"Spiegelberg GmbH & Co. KG","lAP Catheter","MD: Catheter-tip transducer, pressure",SND32.1.11,,"2506, 2711",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241212_27"
Vk_20241212_27,2024-12-20,2024-12-20,,"Spiegelberg GmbH & Co. KG","Silverline Ventricular Probe with Cranial Bolt","MD: Intracerebral infusion/drainage catheter, short-term",SND13.1.14S,,13464,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241212_27"
Vk_20241212_27,2024-12-20,2024-12-20,,"Spiegelberg GmbH & Co. KG","Probe 3PN","MD: Patient monitoring system module, intracranial pressure",SND13.1.53,,81862,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241212_27"
Vk_20241212_27,2024-12-20,2024-12-20,,"Spiegelberg GmbH & Co. KG","Probe 3XL","MD: Intracerebral infusion/drainage catheter, short-term",SND13.1.13XL,,"66056, 66067, 66073, 66074, 66105, 66116, 79228, 79385, 94283, 94284, 94532, 94533, 101721, 103128, 103234, 104413, 106166",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241212_27"
Vk_20241212_27,2024-12-20,2024-12-20,,"Spiegelberg GmbH & Co. KG","Probe 3PN with Trocar","MD: Patient monitoring system module, intracranial pressure",SND13.1.54,,18151,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241212_27"
Vk_20241210_01,2024-12-10,2024-12-20,"Added new language","Dedienne Santé","SYMBOL STEM","MD: Press-fit femoral stem prosthesis","3700502202748; 3700502202731","360460250A; 356880250A",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241210_01"
Vk_20241217_30,2024-12-19,2024-12-20,"Added new language","Olympus Medical Systems Corp.","Thunderbeat Type - S","MD: Soft-tissue ultrasonic surgical system holder/tip, single-use","TB-0535FCS, TB-0545FCS, TB-0520FCS","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241217_30"
Vk_20241220_02,2024-12-20,2024-12-20,,"Datex-Ohmeda Inc.","Tec 6 Plus Vaporizer","MD: Desflurane anaesthesia vaporizer","see FSN",,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241220_02"
Vk_20241220_02,2024-12-20,2024-12-20,,"Datex-Ohmeda Inc.","Tec 820 ISO Vaporizer","MD: Isoflurane anaesthesia vaporizer","see FSN",,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241220_02"
Vk_20241220_02,2024-12-20,2024-12-20,,"Datex-Ohmeda Inc.","Tec 820 SEV Vaporizer","MD: Sevoflurane anaesthesia vaporizer","see FSN",,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241220_02"
Vk_20241220_02,2024-12-20,2024-12-20,,"Datex-Ohmeda Inc.","Tec 850 ISO Vaporizer","MD: Isoflurane anaesthesia vaporizer","see FSN",,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241220_02"
Vk_20241220_02,2024-12-20,2024-12-20,,"Datex-Ohmeda Inc.","Tec 850 SEV Vaporizer","MD: Sevoflurane anaesthesia vaporizer","see FSN",,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241220_02"
Vk_20241213_01,2024-12-20,2024-12-20,,"Maquet Cardiovascular, LLC","Acrobat Product Family","MD: Beating Heart Cardiosurgery Devices - Other","OM-10000Z, OM-9000Z, OM-5000Z","Refer to FSN Attachment",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241213_01"
Vk_20240923_28,2024-09-24,2024-12-19,Follow-up,"Philips Respironics, Inc","Trilogy EV300","MD: Portable electric ventilator",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240923_28"
Vk_20240923_28,2024-09-24,2024-12-19,Follow-up,"Philips Respironics, Inc","Trilogy Evo O2","MD: Portable electric ventilator",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240923_28"
Vk_20240923_28,2024-09-24,2024-12-19,Follow-up,"Philips Respironics, Inc","Trilogy Evo","MD: Portable electric ventilator",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240923_28"
Vk_20231227_18,2023-12-27,2024-12-19,"Resolution of the Potential for Negative Bias","Siemens Healthcare Diagnostics Inc.","Atellica CH Immunoglobulin M_2 (IgM_2)","IVD: Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry",11097620,"221764 and above",N/A,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20231227_18"
Vk_20241210_30,2024-12-19,2024-12-19,,"KLS Martin Group","OP-Leuchtensystem (marLED E, marLED X)","MD: Medical monitor/light mount","89-800-00-00 / 89-903-00-00 / 89-000-00-00",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241210_30"
Vk_20241217_01,2024-12-17,2024-12-19,"Added new language","PhysIOL s.a.","ISOPURE 123","MD: Iols, Aphakic, Monofocal, Aspheric, Hydrophobic Acrylic",,"See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241217_01"
Vk_20241217_01,2024-12-17,2024-12-19,"Added new language","PhysIOL s.a.","MICROPURE 123","MD: Iols, Aphakic, Monofocal, Aspheric, Hydrophobic Acrylic",,"See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241217_01"
Vk_20241217_29,2024-12-19,2024-12-19,,"Olympus Medical Systems Corp.","Single Use Mechanical Lithotriptor V","MD: Manual biliary stone fragmenter","BML-V442QR-30; N2303230","33K, 34K, 35K, 36K, 37K, 38K, 39K, 3XK, 3YK, 3ZK, 41K, 42K, 43K, 44K",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241217_29"
Vk_20241120_10,2024-12-19,2024-12-19,,"Bonree Medical Co., Ltd.","Disposable Electronic Ureteroscope","MD: Ureterorenoscopes",SEPUR3006E,24020301H,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241120_10"
Vk_20241219_05,2024-12-19,2024-12-19,,"Imaxeon Pty Ltd Rydalmere Metro Centre","Medrad Centargo CT Injection System","MD: CT contrast medium injection system, line-powered, mobile","CENT-SYS-BAT, CENT-SYS-OCS",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241219_05"
Vk_20241206_28,2024-12-19,2024-12-19,,"Coloplast A/S","Product families from the interventional urology portfolio","MD: Product families from the interventional urology portfolio, see details in FSN in Appendix 1 version 3.0","see details in FSN in Appendix 1 version 3.0","see details in FSN in Appendix 1 version 3.0",,"Not applicable","https://fsca.swissmedic.ch/mep/#?q=Vk_20241206_28"
Vk_20241209_21,2024-12-10,2024-12-19,"Added new language","Richard Wolf GmbH","SWISS PIEZOCLAST","MD: Electromechanical orthopaedic extracorporeal shock wave therapy system",80414,,"See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241209_21"
Vk_20241219_02,2024-12-19,2024-12-19,,"R-Biopharm AG","RIDA QUICK Rota/Adeno/Noro Combi","IVD: Viral Antigen/antibody Detection - Other",N1903,BH34-BI31.28,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241219_02"
Vk_20210413_16,2021-04-20,2024-12-19,"Information on the implementation of the permanent mitigation","Roche Diagnostics GmbH","IRON 2","IVD: Iron IVD, kit, spectrophotometry",03183696122,All,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20210413_16"
Vk_20241218_28,2024-12-19,2024-12-19,,"GE Medical Systems Israel Functional Imaging","Multiple GEHC Nuclear Medicine systems","MD: Stationary gamma camera system","see FSN",,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241218_28"
Vk_20241218_24,2024-12-19,2024-12-19,,"iThera Medical GmbH","MSOT Acuity Echo CE","MD: Various Radiodiagnostic And Interventional Instruments ¿ Other",SYS-MSOTACUITYechoCE2,,2-21-04,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241218_24"
Vk_20241217_13,2024-12-19,2024-12-19,,"Canon Medical Systems Corporation","Vantage Orian, Vantage Elan, Vantage Titan","MD: Full-body MRI system, superconducting magnet","MRT-1550, MRT-2020, MRT-1504",,S2E20Y2505,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241217_13"
Vk_20241119_29,2024-12-18,2024-12-18,"Added new language","Kirwan Surgical Products LLC","Disposable Bipolar Pencil 25GA Straight","MD: Universal foot-controlled electrosurgical diathermy system conducting unit, single-use","14-5011, 14-5011L","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241119_29"
Vk_20241212_12,2024-12-18,2024-12-18,,"GE OEC Medical Systems, Inc.","OEC Elite","MD: Mobile general-purpose fluoroscopic x-ray system, digital",,,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241212_12"
Vk_20241212_12,2024-12-18,2024-12-18,,"GE OEC Medical Systems, Inc.","OEC 3D","MD: Mobile general-purpose fluoroscopic x-ray system, digital",,,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241212_12"
Vk_20241212_12,2024-12-18,2024-12-18,,"GE OEC Medical Systems, Inc.","OEC 9900","MD: Stationary basic diagnostic x-ray system, digital",,,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241212_12"
Vk_20241212_12,2024-12-18,2024-12-18,,"GE OEC Medical Systems, Inc.","OEC 9800","MD: Stationary angiographic x-ray system, analogue",,,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241212_12"
Vk_20241202_11,2024-12-18,2024-12-18,,"Sedana Medical Limited","Sedaconda Syringe","MD: Respiratory And Anaesthesia Devices - Other",1026022,"Potentially F000044, F000055, F000068, F000069, F000072, F000081",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241202_11"
Vk_20241216_01,2024-12-18,2024-12-18,,"Sarstedt AG & Co.","Blutkultur-Adapter L","IVD: Fittings/Adapters",14.1207,4074421,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241216_01"
Vk_20241216_01,2024-12-18,2024-12-18,,"Sarstedt AG & Co.","Blutkultur-Adapter U","IVD: Fittings/Adapters",14.1209,"4074321, 4074322, 4074521",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241216_01"
Vk_20241210_39,2024-12-18,2024-12-18,,"SPINEART SA","CERVICAL DISC PROSTHESIS BAGUERA C","MD: Cervical total intervertebral disc prosthesis, modular","CDP-TI 13 05-S, CDP-TI 13 06-S","8-4394, 8-4395",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241210_39"
Vk_20241213_03,2024-12-17,2024-12-17,,"Cardiac Pacemaker Inc","Subpopulation of ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).","MD: Pacemaker, implantable, biventricular (Cardiac Re-synchronization Therapy pacemakers); Pacemaker, implant, dual-chamber, rate responsive; Pacemaker, implant, single-chamber, rate-responsive","see FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241213_03"
Vk_20241212_20,2024-12-17,2024-12-17,,"Philips Electronics Nederland B.V.","Philips Azurion system","MD: Stationary general-purpose fluoroscopic x-ray system, analogue",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241212_20"
Vk_20241212_20,2024-12-17,2024-12-17,,"Philips Electronics Nederland B.V.","Allura Xper","MD: Stationary general-purpose fluoroscopic x-ray system, analogue",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241212_20"
Vk_20241204_17,2024-12-04,2024-12-17,"Added new language","Rehaforum Medical GmbH","Wannenbrett mit Griff","MD: Chair/hop bath","09233208 and 01840222","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241204_17"
Vk_20241212_14,2024-12-17,2024-12-17,,"GE Healthcare Japan Corporation","Revolution Ascend","MD: Full-body CT system","See FSN","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241212_14"
Vk_20241212_13,2024-12-17,2024-12-17,,"Medtronic Inc.","DLP One-Piece Pediatric Arterial Cannula 8 Fr","MD: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return",77008,"2024010723, 202404C049",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241212_13"
Vk_20241212_13,2024-12-17,2024-12-17,,"Medtronic Inc.","DLP One-Piece Pediatric Arterial Cannula 14 Fr","MD: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return",77014,2023121097,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241212_13"
Vk_20241212_13,2024-12-17,2024-12-17,,"Medtronic Inc.","EOPA Elongated One Piece Arterial Cannula 18 Fr","MD: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return",77418,2022041038,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241212_13"
Vk_20241212_13,2024-12-17,2024-12-17,,"Medtronic Inc.","EOPA Elongated One Piece Arterial Cannula 22 Fr","MD: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return",77422,2023020934,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241212_13"
Vk_20241212_13,2024-12-17,2024-12-17,,"Medtronic Inc.","Select Series Angled Tip Arterial Cannula 22 Fr","MD: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return",72422,"2023071075, 202309C075",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241212_13"
Vk_20241202_03,2024-12-04,2024-12-17,"Added new language","Arthrex INC","Synergy RF Console","MD: Open-surgery electrosurgical handpiece/electrode, bipolar, single-use",AR-9800,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241202_03"
Vk_20241212_04,2024-12-17,2024-12-17,,"Max Mobility LLC","SpeedControl Dial used with the Smartdrive MX2+","MD: Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible",MX2-3DC,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241212_04"
Vk_20241204_49,2024-12-17,2024-12-17,,"Canon Medical Systems Corporation (ehemals Toshiba Medical Systems Corporation)","X-Ray Interventional Systems","MD: Stationary angiographic x-ray system, digital","INFX-8000C, INFX-8000F, INFX-8000V, INFX-8000H",,"99D1912053, B2A20X2048, A1C16Z2325, A1B16Z2145, A1C1752364, A1B1752157, 99D1952063, F1A2252011, 99D2182129, B2A2182118, 99D1822035",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241204_49"
Vk_20241204_15,2024-12-16,2024-12-16,,"ElitechGroup S.p.A.","ELITe InGenius Consumable Set","IVD: Nucleic Acid Testing Instruments Except Micro-arrays - Consumables",,"114 453, 115 535, 117 336, 118 087",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241204_15"
Vk_20241212_16,2024-12-16,2024-12-16,,"Safersonic Medizinprodukte Handelsges.m.b.H.","Safersonic Regular Sterile Transducer Cover","MD: Wrappers, Sterile","SAF.612.18120.CH; SAF.612.18120.CH",3181130439,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241212_16"
Vk_20241126_12,2024-12-16,2024-12-16,,"Medis Medical Imaging Systems bv","QAngio XA 3D","MD: Laboratory instrument/analyser application software IVD","QAngio XA 3D",,2.2.10.2,2.2.10.2,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241126_12"
Vk_20241209_28,2024-12-16,2024-12-16,,"DH Healthcare GmbH","DeepUnity Viewer 2.x","MD: Picture Archiving And Communication Systems",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241209_28"
Vk_20241202_10,2024-12-13,2024-12-13,,"Medicon eG","Gubisch Osteotom","MD: Plastic surgery osteotome","67.30.53; 67.30.52","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241202_10"
Vk_20241209_25,2024-12-13,2024-12-13,,"DH Healthcare GmbH","DeepUnity Viewer 2.x","MD: Picture Archiving And Communication Systems",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241209_25"
Vk_20241204_43,2024-12-11,2024-12-11,,"CompuGroup Medical Software GmbH","CGM CLINICAL Medication","MD: Medical Device Software - Not Included In Other Classes",,,,"8.x, 9.x, 10.x","https://fsca.swissmedic.ch/mep/#?q=Vk_20241204_43"
Vk_20241127_02,2024-11-27,2024-12-11,"Added new language","Roche Diabetes Care GmbH","Accu-Chek Spirit 3.15 ml Plastic Cartridge","MD: Portable Microinfusion Instruments - Consumables","04949935001 / 05206073001","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241127_02"
Vk_20241127_03,2024-12-03,2024-12-11,"Added new language","Immunotech S.A.S.","Access hsTnI Reagent (High Sensitivity Troponin I)","IVD: Cardiac Markers",B52699,All,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241127_03"
Vk_20241204_42,2024-12-10,2024-12-10,,"Medtronic Navigation Inc.","Sterile Percutaneous Reference Pin","MD: Orthopaedic stereotactic surgery system","9733235, 9733236","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241204_42"
Vk_20241025_13,2024-11-01,2024-12-10,"additional information","Baxter Healthcare SA","MINICAP EXTEND LIFE PD TRANSFER SET","MD: Peritoneal dialysis system tubing set","R5C4482, R5C4484","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241025_13"
Vk_20241210_03,2024-12-10,2024-12-10,,"3M Unitek Corporation","3M Transbond Self-Etching Primer","MD: Dentine bonding agent/set","712-090, 712-091","11093917, 11106533, 11120254, 11153742, 11155372, 11173412, 11165780, 11165793",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241210_03"
Vk_20241210_02,2024-12-10,2024-12-10,,"Biocartis NV","Idylla Instrument","IVD: Nucleic Acid Testing Integreted Extration /amplification /detection Systems","see FSN",,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241210_02"
Vk_20241126_10,2024-12-02,2024-12-09,"Added new language","Tem Innovations GmbH","ROTEM sigma complete","IVD: Other Other Haemostasis Reagents","555501 / 555502","S221203 and higher / S221204 and higher",N/A,N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241126_10"
Vk_20241108_02,2024-11-13,2024-12-09,"Minor change (Addition of FSCA reference number in DE, IT, and EN)","DIABELOOP SA",YourLoops,"MD: Wireless patient monitor/sensor reporting software, layperson-use",,,"All associated devices available on the market",3.4.0,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241108_02"
Vk_20241122_05,2024-12-06,2024-12-06,,COLLIN,"Pointe de stylet pour otologie","MD: Surgical Navigation Instruments - Consumables",PGPOINTER,111590,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241122_05"
Vk_20241108_01,2024-12-06,2024-12-06,,"Greiner Bio-One GmbH","HOLDEX Single-Use Holder PP single-packed, steril","IVD: Luer-ended blood collection tube spike",450263,"A240745B, A24083GD",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241108_01"
Vk_20240906_38,2024-09-10,2024-12-05,,"GE Healthcare","Centricity PACS","MD: Radiological PACS software",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240906_38"
Vk_20241115_13,2024-11-19,2024-12-04,,"Weinmann Emergency Medical Technology GmbH + Co. KG","MEDUMAT Standard 2 with CO2 measurement","MD: Transport electric ventilator","WM 29500","manufactured 2013",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241115_13"
Vk_20241115_13,2024-11-19,2024-12-04,,"Weinmann Emergency Medical Technology GmbH + Co. KG","MEDUMAT Transport with CO2 measurement","MD: Transport electric ventilator","WM 28415, WM 28400, WM 28615","manufactured 2008",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241115_13"
Vk_20241115_13,2024-11-19,2024-12-04,,"Weinmann Emergency Medical Technology GmbH + Co. KG","MEDUMAT Standard with CO2 measurement","MD: Transport electric ventilator","28710-02, 28710-04, 28950, 28944, 29500","manufactured 2013",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241115_13"
Vk_20241115_13,2024-11-19,2024-12-04,,"Weinmann Emergency Medical Technology GmbH + Co. KG","MEDUMAT Transport with CO2 measurement","MD: Transport electric ventilator"," 28415, 28400, 28615","manufactured 2008",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241115_13"
Vk_20240930_17,2024-10-02,2024-12-03,"Added new informations","Baxter Medical Systems GmbH + Co. KG","TruSystem 7000","MD: Universal operating table, electromechanical","1841046, 1841048, 1841049, 1841082, 2065385",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240930_17"
Vk_20241101_02,2024-11-06,2024-12-02,"Additional affected models for BD BACTEC Blood Culture System","Becton, Dickinson and Company","BD Phoenix M50 Automated Microbiology System Instrument","IVD: Microorganism identification/antimicrobial-susceptibility analyser IVD",443624,,"All serial numbers",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241101_02"
Vk_20241101_02,2024-11-06,2024-12-02,"Additional affected models for BD BACTEC Blood Culture System","Becton, Dickinson and Company","BD BACTEC Blood Culture System","IVD: Blood culture analyser IVD","441385, 445475, 442296, 445570, 445570U",,"All serial numbers",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241101_02"
Vk_20241101_02,2024-11-06,2024-12-02,"Additional affected models for BD BACTEC Blood Culture System","Becton, Dickinson and Company","BD MAX System","IVD: Thermal cycler nucleic acid amplification analyser IVD, laboratory",441916,,"All serial numbers",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241101_02"
Vk_20241101_02,2024-11-06,2024-12-02,"Additional affected models for BD BACTEC Blood Culture System","Becton, Dickinson and Company","BD COR System","IVD: Thermal cycler nucleic acid amplification analyser IVD, laboratory","443988, 443989, 443990",,"All serial numbers",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241101_02"
Vk_20241101_02,2024-11-06,2024-12-02,"Additional affected models for BD BACTEC Blood Culture System","Becton, Dickinson and Company","BD EpiCenter Microbiology Data Management System",": Non-IVD","441007, 440887, 440981",,"All serial numbers",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241101_02"
Vk_20241101_02,2024-11-06,2024-12-02,"Additional affected models for BD BACTEC Blood Culture System","Becton, Dickinson and Company","BD Synapsis Informatics Solution",": Non-IVD",444150,,"All serial numbers",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241101_02"
Vk_20241104_19,2024-11-05,2024-12-02,"Added new language","Hermes Medical Solutions AB","Hybrid Recon","MD: Various Instruments For Nuclear Medicine - Medical Device Software",,,,"5.0, 4.0","https://fsca.swissmedic.ch/mep/#?q=Vk_20241104_19"
Vk_20241128_16,2024-12-02,2024-12-02,,"Sofradim Production","ProGrip Self gripping Polyester Mesh","MD: Surgical Meshes, More Than One Component","TEM1509G, TEM1515G","TEM1509G, lot #SYF0106X; TEM1515G, lot #SYF0272X",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241128_16"
Vk_20241126_22,2024-12-02,2024-12-02,,"Epocal Inc.","epoc NXS Host","IVD: Metabolic profile clinical chemistry analyser IVD","SMN 11413475 (US), SMN 11413497 (EU), SMN 11413498 (JP), SMN 11413506 (CA), SMN 11413517 (MX), SMN 11413518 (ROW), SMN 11413583 (CN, KR), SMN 11413879 (IN)",N/A,all,4.14.9,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241126_22"
Vk_20241121_16,2024-11-26,2024-12-02,"Added new language","Becton, Dickinson and Company, BD Biosciences","BD FACSLyric Flow Cytometer","IVD: Flow cytometry analyser IVD","Refer to FSN",,"Refer to FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241121_16"
Vk_20241119_03,2024-12-02,2024-12-02,,"Breas Medical AB","Vivo 45LS","MD: Pulmonary Ventilators For Non¿hospital Use","230072, 230472","Date of manufacture on or before 230831 (31 August 2023)",,"3.1.9 or earlier","https://fsca.swissmedic.ch/mep/#?q=Vk_20241119_03"
Vk_20241111_01,2024-11-13,2024-11-29,"Added new language","Arthrex INC","OATS 2.0 Single-Use Set, 12 mm","MD: Orthopaedic osteotome",ABS-8981-12S,"see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241111_01"
Vk_20241129_08,2024-11-29,2024-11-29,,"Kinova inc","Kinova Jaco assistive robotic arm","MD: Wheelchairs Accessories - Other","PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241129_08"
Vk_20241120_22,2024-11-20,2024-11-29,"Added new language","Oxoid Deutschland GmbH, Thermo Fisher Scientific","Thermo Scientific Yersinia Selective Agar","IVD: GMDN=5032384129140",PO5044A,6190052,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241120_22"
Vk_20241011_42,2024-11-11,2024-11-28,"Additional remark regarding actions to be taken by the users","DH Healthcare GmbH","ORBIS Medication 3.x","MD: General Medicine Instruments - Other",,,,All,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241011_42"
Vk_20241126_13,2024-11-28,2024-11-28,,"The Spectranetics Corporation","Turbo Elite Laser Atherectomy Catheter","MD: Atherectomy laser system beam guide-catheter, peripheral","414-151, 417-152, 420-006, 423-001, 423-135-01, 423-135-02, 425-011, 425-135-01, 425-135-02","all lots",,"Not applicable","https://fsca.swissmedic.ch/mep/#?q=Vk_20241126_13"
Vk_20241121_14,2024-11-27,2024-11-27,,"Medtronic Inc.","SynchroMed Clinician Programmer Application","MD: Implantable Pumps Programmers - Medical Device Software",A810,,all,2.x,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241121_14"
Vk_20241115_22,2024-11-26,2024-11-26,,"Cartiva, Inc.","Cartiva Synthetic Cartilage Implant","MD: Total metatarsophalangeal joint prosthesis, one-piece","CAR-06, CAR-06-AUS, CAR-06-BRZ, CAR-06-US, CAR-08, CAR-08-AUS, CAR-08-BRZ, CAR-08-US, CAR-10, CAR-10-AUS, CAR-10-BRZ, CAR-10-US, CAR-12, CAR-12-AUS, CAR-12-BRZ, CAR-12-US, WDG-10, WDG-15",All,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241115_22"
Vk_20241120_07,2024-11-26,2024-11-26,,"Beckman Coulter , Inc.","Access Intact PTH Reagent","IVD: Parathyroid Hormone Intact",A16972,"see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241120_07"
Vk_20241121_10,2024-11-26,2024-11-26,,"Abbott Medical","MERLIN PATIENT CARE SYSTEM (PCS)","AIMD: Cardiac pulse generator software",3650,,"3650: Software model 3330 28.0.X - 28.1.X Rev 1",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241121_10"
Vk_20241111_17,2024-11-26,2024-11-26,,"DiaSorin Inc","LIAISON QSET Device Plus","IVD: Samples Analyses, Plastic Tubes With Additives",319060,"225084, 233154, 223244, 230094, 259144, 224244, 219104, 228174, 251234, 232094, 236174, 252244, 224124, 210204, 223274, 217134 , 221214, 221294, 234114, 228224, 232294, 205144, 229224, 222314",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241111_17"
Vk_20241114_16,2024-11-25,2024-11-25,,"mbits imaging GmbH",mRay,"MD: Radiology Instruments - Software Accessories","mRay 6.9",,,6.9,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241114_16"
Vk_20241114_12,2024-11-22,2024-11-22,,"Fresenius Kabi AG","Aurora Plasmapheresis System","MD: Apheresis system","6R4601, 4R4601, 4R4601R",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241114_12"
Vk_20241030_04,2024-11-06,2024-11-22,"Acknowledgement Form added in EN","M.A. Med Alliance SA (MedAlliance)","Selution SLR PTCA Balloon Catheter","MD: Coronary angioplasty balloon catheter, drug-coated",SE18-030100,"L92505, L92835, L93029, L93495",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241030_04"
Vk_20241022_18,2024-10-29,2024-11-22,"Added new language","machineMD AG",neos,"MD: Ophtalmology Assessments And Diagnosis Instruments",NEOS-01-CH,"See FSN","See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241022_18"
Vk_20241118_08,2024-11-21,2024-11-21,,"ICU Medical, Inc.","Plum 360 infusion systems","MD: Bedside infusion pump, single-channel","See FSN","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241118_08"
Vk_20241113_03,2024-11-19,2024-11-19,,"Vascutek Ltd","Thoraflex Hybrid","MD: Descending thoracic aorta endovascular stent-graft","N/A; N/A",N/A,N/A,N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241113_03"
Vk_20241115_12,2024-11-19,2024-11-19,,"CompuGroup Medical Software GmbH","CGM CLINICAL Medication","MD: Medical Device Software - Not Included In Other Classes",,,,"9.1, 9.4, 10.2, 11.1","https://fsca.swissmedic.ch/mep/#?q=Vk_20241115_12"
Vk_20241111_10,2024-11-19,2024-11-19,,"Medicon eG","Mercedes Liposuct Kan 15cm","MD: Suction And Irrigation Surgical Cannulas And Handpieces, Reusable",09.88.30,"RSIC3-0023 / RAIS3-0023 / FIIS4-0023",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241111_10"
Vk_20241112_18,2024-11-19,2024-11-19,,"GS Elektromedizinische Geräte G. Stemple GmbH","Battery corpuls aed","MD: DEFIBRILLATORS - HARDWARE",06120,all,all,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241112_18"
Vk_20240426_19,2024-05-21,2024-11-19,"new timeline","Philips Medical Systems Nederland B.V.","Philips MR systems with g-MDU","MD: Full-body MRI system, superconducting magnet","See FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240426_19"
Vk_20241105_31,2024-11-12,2024-11-18,,"Philips Healthcare Enterprise Imaging Informatics","Achieva TX Interventional Coil 3.0T, dS Breast 16c","MD: Full-body MRI system, superconducting magnet","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241105_31"
Vk_20241028_13,2024-11-15,2024-11-15,,"QuidelOrtho (Ortho-Clinical Diagnostics Inc.)","VITROS Chemistry Products CRP Slides","IVD: C-reactive protein (CRP) IVD, reagent",1926740,"1221 (expired 01-Oct-2024) and 1222 (expires 01-Jan-2025)",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241028_13"
Vk_20240424_01,2024-05-03,2024-11-14,"New information","Welch Allyn, Inc.","ProBP 3400 Blood Pressure Device","MD: Automatic-inflation electronic sphygmomanometer, portable, arm/wrist","34XFST-2; PWCD-5WT-2; PWCD-6WT-2","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240424_01"
Vk_20240424_01,2024-05-03,2024-11-14,"New information","Welch Allyn, Inc.","SPOT VISION SCREENER","MD: Vision/eye movement analysis system","VS100S-2; 106364","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240424_01"
Vk_20241105_01,2024-11-06,2024-11-14,"Added new language","Becton, Dickinson and Company","BD BBL Sensi Disc Ampicillin 2 µg (AM-2)","IVD: Antibacterial susceptibility testing disc IVD",231263,"see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241105_01"
Vk_20240516_04,2024-05-16,2024-11-12,"SW Update is now available","Fresenius Medical Care AG & Co. KGaA",multiFiltratePRO,"MD: Haemodialysis system, institutional/home-use",M205001,,,"Software versions 6.02 and 5.02","https://fsca.swissmedic.ch/mep/#?q=Vk_20240516_04"
Vk_20241106_01,2024-11-12,2024-11-12,,"Siemens Healthcare Diagnostics Inc.","Atellica CI Analyzer","IVD: Multiple clinical chemistry analyser IVD, laboratory",10947347,,,1.28.51,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241106_01"
Vk_20241104_17,2024-11-11,2024-11-11,,"Boston Scientific Corporation","Acurate neo2 and Prime Aortic Valve System","MD: Aortic transcatheter heart valve bioprosthesis, stent-like framework","See FSN","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241104_17"
Vk_20241011_43,2024-11-11,2024-11-11,,"DH Healthcare GmbH","ORBIS Medication 3.x","MD: General Medicine Instruments - Other",,,,03.17.01.00,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241011_43"
Vk_20241104_14,2024-11-08,2024-11-08,,"Medtronic Inc.","Becker and Exacta External Drainage and Monitoring Systems","MD: Cerebrospinal fluid external drainage kit","24146, 25120, 26040, 27581, 27609, 27636, 27666, 27670, 27672, 27702, 27732, 27779, 27785, 27795, 27811, 46129, 46700, 46705",All,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241104_14"
Vk_20241024_39,2024-11-05,2024-11-08,"Added new language","KayserBetten GmbH & Co. KG","KayserBett OLAF","MD: Electrical assistive bed","OLAF 98 & OLAF 135",,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241024_39"
Vk_20241024_32,2024-11-05,2024-11-08,"Added new language","KayserBetten GmbH & Co. KG","KayserBett OLAF","MD: Electrical assistive bed","OLAF 98 & OLAF 135",,"SN 017071, SN 018594, SN 019400, SN 019503, SN 019716",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241024_32"
Vk_20241029_24,2024-11-05,2024-11-08,"Added new language","KayserBetten GmbH & Co. KG","KayserBett EMMA","MD: Electrical assistive bed","EMMA1, EMMA2",,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241029_24"
Vk_20241029_24,2024-11-05,2024-11-08,"Added new language","KayserBetten GmbH & Co. KG","KayserBett IDA","MD: Electrical assistive bed",IDA,,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241029_24"
Vk_20241015_28,2024-10-22,2024-11-07,"Added new language","Philips Medical Systems Nederland B.V.","Vue PACS","MD: Radiological PACS software",1149418,,,v12,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241015_28"
Vk_20240228_03,2024-03-05,2024-11-07,"Update FSN","Beckman Coulter , Inc.","Access Substrate","IVD: Substrates",81906,"see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240228_03"
Vk_20241101_22,2024-11-06,2024-11-06,,"Biomet Sports Medical llc","JuggerLoc Drill Guide","MD: General surgical procedure kit, non-medicated, single-use",110027357,"See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241101_22"
Vk_20241101_03,2024-11-06,2024-11-06,,"Siemens Healthcare Diagnostics Inc.","Atellica CH ß2-Microglobulin","IVD: Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry",11097635,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241101_03"
Vk_20240708_09,2024-07-09,2024-11-06,"Korrektur wegen Dokumentenverwechslung durch Hersteller","Philips Respironics, Inc","BiPAP A40 Pro","MD: Portable electric ventilator","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240708_09"
Vk_20240708_09,2024-07-09,2024-11-06,"Korrektur wegen Dokumentenverwechslung durch Hersteller","Philips Respironics, Inc","BiPAP A40 EFL","MD: Portable electric ventilator","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240708_09"
Vk_20240708_09,2024-07-09,2024-11-06,"Korrektur wegen Dokumentenverwechslung durch Hersteller","Philips Respironics, Inc","BiPAP A30 EFL","MD: Portable electric ventilator","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240708_09"
Vk_20241018_18,2024-10-22,2024-11-06,"Added new language","Karl Storz SE und Co. KG","Aggressive Cutter, Full Radius Resector & Aggr. Pro Line Shaver Blade; sterile","MD: Arthroscopic shaver system blade, single-use","28208BKS, 28206CBS, 28205NDS","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241018_18"
Vk_20241018_18,2024-10-22,2024-11-06,"Added new language","Karl Storz SE und Co. KG","Aggressive Barrel Burr","MD: Orthopaedic bur, single-use","28205HES, 28205HDS","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241018_18"
Vk_20241018_18,2024-10-22,2024-11-06,"Added new language","Karl Storz SE und Co. KG","Round Burr, Finish Barrel Burr & Semi Hooded Barrel Burr; sterile","MD: Orthopaedic bur, single-use","28205FDS, 28205GDS, 28208IDS","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241018_18"
Vk_20240930_20,2024-10-01,2024-11-06,"updated FSN d,f,i","Philips Medical Systems Nederland B.V.","Zenition 50","MD: Stationary general-purpose fluoroscopic x-ray system, digital",718096,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240930_20"
Vk_20240930_20,2024-10-01,2024-11-06,"updated FSN d,f,i","Philips Medical Systems Nederland B.V.","Zenition 70","MD: Stationary general-purpose fluoroscopic x-ray system, digital",718133,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240930_20"
Vk_20231127_06,2023-12-11,2024-11-06,"expanded FSN, wrongly impacted MD put on the market","Ecolab Deutschland GmbH","Incidin OxyWipe S","MD: Medical device cleaning/disinfection wipe","3082240; 3116020; 3092040; 3116100; ","all Lots","all S/N",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20231127_06"
Vk_20231127_06,2023-12-11,2024-11-06,"expanded FSN, wrongly impacted MD put on the market","Ecolab Deutschland GmbH","Incidin OxyFoam S","MD: Medical device disinfection agent","3115790; 3115900; 3082060; 3087450","all Lots","all S/N",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20231127_06"
Vk_20241016_25,2024-11-05,2024-11-05,,"D.O.R.C. Dutch Ophthalmic Research Center","Silicone Oil Syringe","MD: Vitreous humour replacement medium, postoperative","SIL-1000-S, SIL-2000-S, SIL-5000-S",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241016_25"
Vk_20241030_17,2024-11-05,2024-11-05,,"ICU Medical","Tracheal Tube Introducer","MD: Endotracheal tube introducer, reusable",14-504-17,"see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241030_17"
Vk_20241030_17,2024-11-05,2024-11-05,,"ICU Medical","Tracheal Tube Guide","MD: Endotracheal tube guide, reusable","14-504-68, 14-504-76","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241030_17"
Vk_20241024_31,2024-11-05,2024-11-05,,"Advanced Medical Solutions Limited","Biatain Alginate","MD: Exudate-absorbent dressing, hydrophilic-gel, antimicrobial","see FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241024_31"
Vk_20241010_18,2024-10-18,2024-11-01,"additional devices affected, additional languages","SLE Ltd","Reusable and Single Use Flow Sensors","MD: Breathing circuit gas-flow sensor, single-use/reusable","N5402-REV2, N5302/05, N5302/50, L6000/SU, L6000/SU/DHW, NA5000/RU/01, NA5000/RU/02, NA5000/SU/01",,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241010_18"
Vk_20241023_17,2024-10-29,2024-11-01,"Added new language","Welch Allyn, Inc.","Welch Allyn Diagnostic Cardiology Suite","MD: Electrocardiograph, professional, multichannel",,,,V2.1.0,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241023_17"
Vk_20241023_17,2024-10-29,2024-11-01,"Added new language","Welch Allyn, Inc.","Connex Cardio","MD: Diagnostic spirometer, professional",,,,"V1.0.0 - V1.1.1","https://fsca.swissmedic.ch/mep/#?q=Vk_20241023_17"
Vk_20241023_17,2024-10-29,2024-11-01,"Added new language","Welch Allyn, Inc.",Rscribe,"MD: Electrocardiograph, professional, multichannel",,,,"V6.0.0 - V6.2.3","https://fsca.swissmedic.ch/mep/#?q=Vk_20241023_17"
Vk_20241023_17,2024-10-29,2024-11-01,"Added new language","Welch Allyn, Inc.",Hscribe,"MD: Electrocardiographic long-term ambulatory recording analyser application software",,,,"V4.0.0 - V4.34, V6.1.0 - V6.4.1","https://fsca.swissmedic.ch/mep/#?q=Vk_20241023_17"
Vk_20241023_17,2024-10-29,2024-11-01,"Added new language","Welch Allyn, Inc.",Q-Stress,"MD: Cardiopulmonary stress exercise monitoring system computer",,,,"V6.0.0 - V6.3.2","https://fsca.swissmedic.ch/mep/#?q=Vk_20241023_17"
Vk_20241023_17,2024-10-29,2024-11-01,"Added new language","Welch Allyn, Inc.","Vision Express","MD: Electrocardiographic long-term ambulatory recording analyser application software",,,,"V6.1.0 - V6.4.1","https://fsca.swissmedic.ch/mep/#?q=Vk_20241023_17"
Vk_20241023_17,2024-10-29,2024-11-01,"Added new language","Welch Allyn, Inc.",Xscribe,"MD: Cardiopulmonary stress exercise monitoring system computer",,,,"V6.0.0 - V6.3.2","https://fsca.swissmedic.ch/mep/#?q=Vk_20241023_17"
Vk_20241029_01,2024-10-29,2024-11-01,,"Gambro Lundia AB","AK 98","MD: Haemodialysis system, institutional/home-use","115244, 115248, 115249, 115250, 955106, 955403, 955404, 955406, 955989",,"All serials with runtime less than 500 hours",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241029_01"
Vk_20240620_26,2024-06-25,2024-11-01,"Follow-up FSN f,i","Baxter Medical Systems GmbH + Co. KG","iLED 7","MD: Operating room light","4068110, 4068120, 4068140, 4068210, 4068310, 4068410",All,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240620_26"
Vk_20241024_06,2024-11-01,2024-11-01,,"Cook Endoscopy","Hemospray Endoscopic Hemostat","MD: Non-organic haemostatic agent","HEMO-7, HEMO-10, HEMO-7-EU","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241024_06"
Vk_20241001_27,2024-10-09,2024-10-31,"New Information","Gyrus ACMI, Inc.","UroPass Ureteral Access Sheath Set","MD: Dilator, Catheter","See FSN",All,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241001_27"
Vk_20241018_28,2024-10-22,2024-10-30,"Added new language","Terumo BCT, Inc.","COBE 2991 Cell Processor System","MD: Blood transfer set","90819 and 90901","see FSN",,N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241018_28"
Vk_20241028_11,2024-10-30,2024-10-30,,"Fresenius Kabi AG","Lovo Disposable Kits","MD: Blood Transfer Bag",X6R4909A,"FA23K16049, FA24A09217",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241028_11"
Vk_20241028_02,2024-10-30,2024-10-30,,"MAQUET Cardiopulmonary GmbH","Universal Remote Control","MD: Medical device remote control keypad",100925A0,,"All serial numbers",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241028_02"
Vk_20240924_27,2024-10-16,2024-10-30,"Added new language","OSCOR Inc.","Axillary Insertion lntroducers and Introducer Kits","MD: Vascular catheter introduction set, nonimplantable",AB-81-006Z-B,"1554119, 1588790, 1602807, 1605010, 1621646, 1638352, 1652405, 1668195, 1672375, 1680301, 1686703, 1702341, 1706967, 1713870, 1717202, 1729155, 1745030",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240924_27"
Vk_20241028_39,2024-10-29,2024-10-29,,"Boston Scientific Corporation","AMS 800 Artificial Urinary Sphincter","MD: Urethral sphincter prosthesis, non-powered","See FSN","See FSN","See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241028_39"
Vk_20241015_23,2024-10-16,2024-10-29,"Added new language","Radiometer Medical","safePICO A","IVD: Blood gas syringe IVD, sodium heparin",957-204,All,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241015_23"
Vk_20241022_20,2024-10-29,2024-10-29,,"Hyaltech Ltd",Z-Hyalin,"MD: Vitreous/aqueous humour replacement medium, intraoperative","003500-0026-896 & 003500-0055-885","10351CA, 10370BC, 10370AA, 10362BA, 10351CC, 10370BD",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241022_20"
Vk_20241025_01,2024-10-25,2024-10-29,"Added new language","Siemens Healthcare Diagnostics Inc.","Atellica CH Reaction Cuvette Segment","IVD: Laboratory analyser cuvette IVD, reusable","SMN 11099326","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241025_01"
Vk_20241008_19,2024-10-17,2024-10-29,"Added new language","Olympus Medical Systems Corp.","Single Use Biopsy Valve","MD: Endoscope working-channel valve, single-use","MAJ-1555 Single Use Biopsy Valve; N3043000","1YH, 1ZH, 21H, 22H, 23H.",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241008_19"
Vk_20240906_22,2024-10-28,2024-10-28,,"Meridian Medical d.o.o.","MR Q SLT","MD: Neodymium Surgical Laser",s,,"1400-015, 1400-087",QS.01.01.04,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240906_22"
Vk_20241007_32,2024-10-08,2024-10-28,"Added new language","Panthera AB","Side Guard","MD: Push-rim manual wheelchair, non-bariatric","4422033, 4422034, 4423033, 4423034",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241007_32"
Vk_20241009_15,2024-10-15,2024-10-28,"Added new language","Olympus Winter & Ibe GmbH","Outer sheath, 22.5 Fr.","MD: Cystoscopes, Rigid",WA22810A,,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241009_15"
Vk_20240310_15,2024-03-12,2024-10-25,"Added new language","DiaMed GmbH",LISS/Coombs,"IVD: Polyspecific antihuman globulin/complement IVD, antibody","see FSN","all lots currently in use and future lots until further notice",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240310_15"
Vk_20240310_15,2024-03-12,2024-10-25,"Added new language","DiaMed GmbH","Coombs Anti-IgG","IVD: Polyspecific antihuman globulin/complement IVD, antibody","see FSN","all lots currently in use and future lots until further notice",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240310_15"
Vk_20240310_15,2024-03-12,2024-10-25,"Added new language","DiaMed GmbH","ID-Diacell I-II-III","IVD: Antibody screening reagent red blood cell IVD, kit, agglutination","see FSN","all lots currently in use and future lots until further notice",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240310_15"
Vk_20240310_15,2024-03-12,2024-10-25,"Added new language","DiaMed GmbH","ID-DiaCell I-II-III Asia","IVD: Antibody screening reagent red blood cell IVD, kit, agglutination","see FSN","all lots currently in use and future lots until further notice",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240310_15"
Vk_20240310_15,2024-03-12,2024-10-25,"Added new language","DiaMed GmbH","ID DiaScreen ID number 50571","IVD: Polyspecific antihuman serum","see FSN","all lots currently in use and future lots until further notice",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240310_15"
Vk_20241017_24,2024-10-22,2024-10-25,"Added new language","Radiometer Medical",TCM5,"MD: Transcutaneous blood gas monitoring system",393-500,,,"1.5.0, 1.5.0.1","https://fsca.swissmedic.ch/mep/#?q=Vk_20241017_24"
Vk_20241011_47,2024-10-23,2024-10-23,,"Drägerwerk AG & Co. KGaA",Atlan,"MD: Anesthesia Units","8621100, 8621300, 8621400, 8621500, 8621600",,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241011_47"
Vk_20241021_07,2024-10-22,2024-10-22,,"LivaNova Deutschland GmbH","Essenz Perfusion System","MD: Heart-Lung Bypass Units",49-00-10,,"49PK00205, 49PK00244, 49PK00246, 49PK00279, 49PK00206, 49PK00204, 49PK00454, 49PK00489",1.5,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241021_07"
Vk_20241014_20,2024-10-22,2024-10-22,,"EFB Elektronik GmbH","Netzwerk-Isolator Cat.6A Buchse","MD: Network Isolator",NET-ISOADAPRJ45,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241014_20"
Vk_20241014_20,2024-10-22,2024-10-22,,"EFB Elektronik GmbH","Netzwerk-Isolator Cat.6A Stecker","MD: Network Isolator",NET-ISOKABELRJ45,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241014_20"
Vk_20241015_27,2024-10-22,2024-10-22,,"Medtronic MiniMed","MiniMed 640G Insulin Pump","MD: Ambulatory insulin infusion pump, electronic","MMT-1711, MMT-1712, MMT-1751, MMT-1752",,all,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241015_27"
Vk_20241015_27,2024-10-22,2024-10-22,,"Medtronic MiniMed","MiniMed 670G Insulin Pump","MD: Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm","MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782",,all,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241015_27"
Vk_20241015_27,2024-10-22,2024-10-22,,"Medtronic MiniMed","MiniMed 720G Insulin Pump","MD: Ambulatory insulin infusion pump, electronic, non-software-dosing","MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867",,all,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241015_27"
Vk_20241015_27,2024-10-22,2024-10-22,,"Medtronic MiniMed","MiniMed 740G Insulin Pump","MD: Ambulatory insulin infusion pump, electronic, software-dosing, binary algorithm","MMT-1811, MMT-1812, MMT-1861, MMT-1862",,all,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241015_27"
Vk_20241015_27,2024-10-22,2024-10-22,,"Medtronic MiniMed","MiniMed 770G Insulin Pump","MD: Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm","MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892",,all,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241015_27"
Vk_20241015_27,2024-10-22,2024-10-22,,"Medtronic MiniMed","MiniMed 780G Insulin Pump","MD: Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm","MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896",,all,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241015_27"
Vk_20241015_27,2024-10-22,2024-10-22,,"Medtronic MiniMed","MiniMed 630G Insulin Pump","MD: Ambulatory insulin infusion pump, electronic, software-dosing, binary algorithm","MMT-1714, MMT-1715, MMT-1754, MMT-1755",,all,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241015_27"
Vk_20241015_27,2024-10-22,2024-10-22,,"Medtronic MiniMed","MiniMed 620G Insulin Pump","MD: Ambulatory insulin infusion pump, electronic, non-software-dosing","MMT-1710, MMT-1750",,all,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241015_27"
Vk_20241015_27,2024-10-22,2024-10-22,,"Medtronic MiniMed","MiniMed 700G Insulin Pump","MD: Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm","MMT-1801, MMT-1805, MMT-1850, MMT-1851",,all,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241015_27"
Vk_20240828_26,2024-10-02,2024-10-22,"Added FSN for Distributor","Fisher & Paykel Healthcare Ltd","Airvo 3","MD: Professional high-flow respiratory unit, humidifying, manual",PT301EW,,"22092HN20 22092HN3V 23115HK2D 23023629P 23115HC5H 22093BR6T 23032H47B 22082959K 22082989M 24012WT5H 22082939H 22082969F","1.2.0 - 1.5.1","https://fsca.swissmedic.ch/mep/#?q=Vk_20240828_26"
Vk_20241021_26,2024-10-22,2024-10-22,,"ID GmbH & Co. KGaA","ID MEDICS","MD: Medical Device Software - Not Included In Other Classes",,,,"7.10.46 / 7.11.22","https://fsca.swissmedic.ch/mep/#?q=Vk_20241021_26"
Vk_20241017_02,2024-10-22,2024-10-22,,"Olympus Medical Systems Corp.","EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE","MD: Flexible video gastroduodenoscope","GIF-1TH190; N4505840, N4505850",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241017_02"
Vk_20241011_02,2024-10-22,2024-10-22,,"nal von minden GmbH","nal von minden Drug- Screen COC 300 Test","IVD: Cocaine + Cocaine Metabolites - RT & POC",620045,182315,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241011_02"
Vk_20241015_26,2024-10-22,2024-10-22,,INOSYSTEMS,"SoKINOX / ServiNO / Monnal iNO","MD: Nitric oxide delivery unit, system-based","IN000100; IN000101; IN000103; IN000104; IN000105; IN000106; IN000108; IN000109; IN000111; IN000112; IN000120; IN000121; IN000122; IN000123; IN000254; IN000260; IN000261; IN000262; IN000263; IN000264; IN000265; IN000266; IN000267; IN000272",,all,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241015_26"
Vk_20241011_17,2024-10-17,2024-10-22,"New language and repair advice","Merivaara Corporation","Merivaara Q-Flow surgical lights","MD: Operating room light system","Q-FLOW SOLO, Q-FLOW DUO, Q-FLOW TRIO, Q-FLOW QUAD, , Q-FLOW MOBILE","manufactured before 2023","All devices between 2017 (start of manufacturing) - June 2023",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241011_17"
Vk_20241011_03,2024-10-15,2024-10-21,"Added new language","Boston Scientific Corporation",PolarX,"MD: Cardiac cryosurgical system catheter","M004CRBS2000, M004CRBS2100",all,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241011_03"
Vk_20241011_03,2024-10-15,2024-10-21,"Added new language","Boston Scientific Corporation",POLARxFit,"MD: Cardiac cryosurgical system catheter","M004CRBS2010, M004CRBS2060, M004CRBS2110, M004CRBS2160",all,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241011_03"
Vk_20240924_01,2024-10-02,2024-10-16,"Aded new lots",Cepheid,XpertXpressCoV-2plus,"IVD: Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)",XP3SARS-COV2-10,"See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240924_01"
Vk_20240924_01,2024-10-02,2024-10-16,"Aded new lots",Cepheid,"XpertXpressCoV-2/Flu/RSVplus","IVD: Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)",P3COV2/FLU/RSV-10,"See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240924_01"
Vk_20241010_08,2024-10-16,2024-10-16,,"Epic Systems Corporation","Regulated Decision Support Framework","MD: Clinical management support software",,,,"See FSN","https://fsca.swissmedic.ch/mep/#?q=Vk_20241010_08"
Vk_20241011_01,2024-10-15,2024-10-15,,"Fresenius Kabi AG","Orchestra- and Pilot-Series","MD: Bedside syringe pump","Z174025, Z174031",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241011_01"
Vk_20240923_07,2024-09-25,2024-10-15,"Added new language","Actim Oy","Actim Partus Test","IVD: Rapid Tests & Point Of Care - Immunochemistry - Other",31931ETAL,2005341,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240923_07"
Vk_20240130_16,2024-02-06,2024-10-14,"Update FSN","Siemens Healthcare Diagnostics Inc.","Atellica IM Erythropoietin (EPO)","IVD: Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay",10733006,"53982039, 55439041",N/A,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240130_16"
Vk_20240130_16,2024-02-06,2024-10-14,"Update FSN","Siemens Healthcare Diagnostics Inc.","ADVIA Centaur Erythropoietin (EPO)","IVD: Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay",10995096,"53984040, 55443042",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240130_16"
Vk_20240904_07,2024-10-14,2024-10-14,,"ORTHOPLUS SAS","Pediatric Labial Interceptor with Stop","MD: Orthodontic Devices - Other","D595 010P",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240904_07"
Vk_20241002_16,2024-10-08,2024-10-10,"Added new language","Arthrex INC","Femoral ACL Marking Hook, AM Portal, 7 mm Offset","MD: Surgical drill guide, reusable",AR-1510F-02,1068582412,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241002_16"
Vk_20240925_03,2024-10-09,2024-10-09,,"Roche Diagnostics GmbH","CoaguChek PT Test","IVD: Prothrombin Time Rt & Poc","06688721070, 06688721016, 06688721019","77409111, 77409112, 77409113",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240925_03"
Vk_20241004_13,2024-10-08,2024-10-08,,"SINOVO health solutions GmbH","mylife App","MD: General Medicine Therapeutic Treatment Instruments - Software Accessories",,,,2.4.0,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241004_13"
Vk_20241004_01,2024-10-08,2024-10-08,,"B. Braun Melsungen AG","Infusomat Space Line ENFit","MD: Electric infusion pump administration set, single-use",8250830SP,"23L27F0000, 22B16F0000, 23B21F0000, 23F21F0000",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241004_01"
Vk_20240930_10,2024-10-02,2024-10-02,,"Cook Incorporated","Approach Hydro ST Micro Wire Guide","MD: Peripheral vascular guidewire, manual","HMW-14-135-ST; G52937","15735501, 15907468",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240930_10"
Vk_20240924_15,2024-10-02,2024-10-02,,"Agfa HealthCare","Enterprise Imaging XERO Viewer","MD: Radiological PACS software",,,,"software version 8.x","https://fsca.swissmedic.ch/mep/#?q=Vk_20240924_15"
Vk_20240930_15,2024-10-02,2024-10-02,,"ICU Medical","15mm Double Swivel Connector 10/BX","MD: Tube/mask breathing circuit connector, single-use, sterile",,"4122008, 4138707",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240930_15"
Vk_20240930_15,2024-10-02,2024-10-02,,"ICU Medical","Portex orator speaking valve for tracheostomy tube 2/CA","MD: Tracheostomy tube speech valve",,"4097683, 4100700, 4107294, 4122007, 4131840",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240930_15"
Vk_20240930_15,2024-10-02,2024-10-02,,"ICU Medical","Nasopharyngeal Airway 6.0MM 10/BX","MD: Nasopharyngeal airway, single-use",,4115880,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240930_15"
Vk_20240930_15,2024-10-02,2024-10-02,,"ICU Medical","Nasopharyngeal Airway 7.0MM 10/BX","MD: Nasopharyngeal airway, single-use",,"4097684, 4110350, 4115879, 4122013, 4130777, 4156815",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240930_15"
Vk_20240930_15,2024-10-02,2024-10-02,,"ICU Medical","Nasopharyngeal Airway 8.0MM 10/BX","MD: Nasopharyngeal airway, single-use",,"4107296, 4112944, 4125005, 4127687, 4141737, 4147168",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240930_15"
Vk_20240930_15,2024-10-02,2024-10-02,,"ICU Medical","15mm Y PIECE 10/CA","MD: Heat/moisture exchanger, single-use",,"4092461, 4147818, 4150795",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240930_15"
Vk_20240927_13,2024-10-01,2024-10-01,,"Integra LifeSciences Corp","Codman Surgical Strips","MD: Neurosurgical sponge","801449 , 801450 , 801451 , 801452 , 801453 , 801454 , 801455 , 801456 , 801457","All unexpired lot numbers ( 5 years expiration)",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240927_13"
Vk_20240927_13,2024-10-01,2024-10-01,,"Integra LifeSciences Corp","Codman Surgical Patties","MD: Neurosurgical sponge","801396 , 801397 , 801398 , 801399 , 801400 , 801401 , 801402 , 801403 , 801404 , 801406 , 801407 , 801408 , 801409","All unexpired lot numbers ( 5 years expiration)",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240927_13"
Vk_20240913_03,2024-09-18,2024-09-26,"Added new language","MAQUET Cardiopulmonary GmbH","MEERA operating table with autodrive","MD: Universal operating table, electrohydraulic",FSN,,FSN,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240913_03"
Vk_20240923_30,2024-09-25,2024-09-25,,"Elekta Instrument AB","Disposable Biopsy Needle Kit","MD: Neurological stereotactic surgery system",911933,873874875R,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240923_30"
Vk_20240923_25,2024-09-25,2024-09-25,,"Gyrus ACMI, Inc.","SG PK CUTTING FORCEPS","MD: Endoscopic electrosurgical handpiece/electrode, bipolar, single-use","TPK-CF0533; PK-CF0533","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240923_25"
Vk_20240923_24,2024-09-24,2024-09-24,,"Smiths Medical ASD, Inc.","CADD-Solis Li-ion Rechargeable Battery Packs","MD: Portable/mobile rechargeable battery pack",21-2160-XX,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240923_24"
Vk_20240131_11,2024-02-06,2024-09-24,"New information, software update avilable","Fujifilm Corporation","FDR Nano","MD: Mobile basic diagnostic x-ray system, digital","DR-XD 1000",,"All devices",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240131_11"
Vk_20240919_20,2024-09-24,2024-09-24,,"B-K Medical AS","Ultrasound system type 2300","MD: General-purpose ultrasound imaging system","bk3000, bk3500, bk5000, bkActiv",,"2300-11, 2300-61, 2300-66",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240919_20"
Vk_20240918_08,2024-09-24,2024-09-24,,"Medtronic Inc.","Recharger Kit","MD: Cerebral Implantable Neurostimulators - Accessories; Spinal Implantable Neurostimulators - Accessories","RS6230, RS7230",,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240918_08"
Vk_20240905_01,2024-09-11,2024-09-24,"Added new language","Bordier Affinity Products SA","Strongyloides ratti IgG ELISA","IVD: Parasitology - Other",9450,2419S,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240905_01"
Vk_20240918_15,2024-09-24,2024-09-24,,"Olympus KeyMed KeyMed House, Stock Road","Olympus OFP-2 Flushing pump","MD: Surgical irrigation pump",K10001143,,"222331548, 22331366, 22332334",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240918_15"
Vk_20240923_20,2024-09-24,2024-09-24,,"ICU Medical","CADD-Solis AC Adapter","MD: Basic power supply, reusable",21-0270-25,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240923_20"
Vk_20240725_25,2024-07-30,2024-09-23,,"Covidien LLC","McGRATH MAC Video Laryngoscope","MD: Video Laryngoscopes","300-000-000, 301-000-000",,"300-000-000: All serial numbers between 366170 to 405673; , 301-000-000: All serial numbers",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240725_25"
Vk_20240913_76,2024-09-17,2024-09-20,"Added new language","Boston Scientific CRM","PROPONENT MRI","AIMD: Dual-chamber implantable pacemaker, rate-responsive",L231,,"See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240913_76"
Vk_20240913_76,2024-09-17,2024-09-20,"Added new language","Boston Scientific CRM","ACCOLADE MRI","AIMD: Dual-chamber implantable pacemaker, rate-responsive",L331,,"See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240913_76"
Vk_20240913_76,2024-09-17,2024-09-20,"Added new language","Boston Scientific CRM","ESSENTIO MRI","AIMD: Dual-chamber implantable pacemaker, rate-responsive",L131,,"See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240913_76"
Vk_20240916_23,2024-09-20,2024-09-20,,"Illumina, Inc","NovaSeq 6000Dx Instrument with DRAGEN Server","IVD: Nucleic acid sequence analyser IVD, next-generation sequencing (NGS)",20068232,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240916_23"
Vk_20240916_23,2024-09-20,2024-09-20,,"Illumina, Inc","Illumina DRAGEN Server for NextSeq 550Dx","IVD: Nucleic acid sequence analyser IVD, next-generation sequencing (NGS)",20086130,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240916_23"
Vk_20240913_29,2024-09-17,2024-09-19,"Added new language","Tosoh Corporation","501RP+","IVD: High Performance Liquid Chromatography Systems - Ivd Medical Device Software",0023295,N/A,N/A,"v2.42 and previous versions","https://fsca.swissmedic.ch/mep/#?q=Vk_20240913_29"
Vk_20240618_02,2024-06-21,2024-09-18,Update,"Proteomedix AG","Proclarix Risk Calculator","IVD: Mixed Panel Multiparameter Analysers - Ivd Medical Device Software","PCLX RICALI",,,"V2.1.1 and V2.2.1","https://fsca.swissmedic.ch/mep/#?q=Vk_20240618_02"
Vk_20240916_26,2024-09-18,2024-09-18,,"Abbott Molecular Inc.","Alinity m STI Amplification Kit","IVD: Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)","09N17-090; 09N17-091; 09N17-095 (US only)","all within date lot numbers",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240916_26"
Vk_20240916_26,2024-09-18,2024-09-18,,"Abbott Molecular Inc.","Alinity m HR HPV Amplification Kit","IVD: Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)","09N15-090; 09N15-091 (Canada only); 09N15-095 (US only)",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240916_26"
Vk_20240916_26,2024-09-18,2024-09-18,,"Abbott Molecular Inc.","Alinity m System","IVD: Nucleic Acid Testing Integreted Extration /amplification /detection Systems","08N53-002; 08N53-032",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240916_26"
Vk_20240906_26,2024-09-17,2024-09-17,,"B. Braun Melsungen AG","Spaceplus Perfusor (with TOM functionality)","MD: Bedside syringe pump",8719030,,,"C02, C03, C04","https://fsca.swissmedic.ch/mep/#?q=Vk_20240906_26"
Vk_20240830_15,2024-09-17,2024-09-17,,"Ambu A/S","Ambu VivaSight 2 DLT","MD: Endobronchial tube","412351000 , 412371000, 412391000, 412411000","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240830_15"
Vk_20240913_77,2024-09-17,2024-09-17,,"Olympus Medical Systems Corp.","EVIS X1 Bronchovideoscope","MD: Data management system","BF-H1100, BF-1TH1100; N6130950, N6130650",,"Please refer to the spreadsheet with affected Serial Numbers submitted as a separate file",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240913_77"
Vk_20240913_77,2024-09-17,2024-09-17,,"Olympus Medical Systems Corp.","EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE","MD: Flexible video gastroduodenoscope","GIF-H190N; N5780950",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240913_77"
Vk_20240913_77,2024-09-17,2024-09-17,,"Olympus Medical Systems Corp.","EVIS EXERA III Small Intestinal Videoscope","MD: Flexible video enteroscope","SIF-H190; N6130350",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240913_77"
Vk_20240913_77,2024-09-17,2024-09-17,,"Olympus Medical Systems Corp.","EVIS X1 Gastrointestinal Videoscope","MD: Flexible video gastroduodenoscope","GIF-1100; N6019450",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240913_77"
Vk_20240614_29,2024-06-18,2024-09-17,"Information which systems are NOT in scope of the FSCA","Hologic, Inc.","Horizon DXA System","MD: Bone absorptiometric x-ray system, dual-energy","Horizon A / Horizon C / Horizon W / Horizon Ci / Horizon Wi",,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240614_29"
Vk_20240913_55,2024-09-17,2024-09-17,,"CODAN pvb Critical Care GmbH","Monitoring set, single, 9003, 3 ml/h, ABSS","MD: Invasive Blood Pressure Monitoring Instruments","Monitoring Set, single; 74.6641","983820, 984372",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240913_55"
Vk_20240904_22,2024-09-10,2024-09-16,"CH-specific model- and lot-numbers","SAV Liquid Production GmbH","Formaldehyde solution 4% buffered","IVD: Fixing reagents (Histology/Cytology)","FN-60180-4-1; 87-0980-00-10024 (LA-BS-FN-120180-4-1), 87-0980-00-Neutral-D (LA-BS-FN-120180-4-2), 87-0980-00-Unilabs (LA-BS-FN-120180-4-3), 87-0980-00-Neutral-F (LA-BS-FN-120180-4-4), 87-0980-00-Neutral-I (LA-BS-FN-120180-4-5)","12489964; 12498554, 12482100, 1248554",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240904_22"
Vk_20240904_22,2024-09-10,2024-09-16,"CH-specific model- and lot-numbers","SAV Liquid Production GmbH","Formaldehyde solution 4.5% buffered","IVD: Fixing reagents (Histology/Cytology)",FN-60180-45-1,12443377,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240904_22"
Vk_20240906_34,2024-09-16,2024-09-16,,"Croma Pharma GmbH","NuVisc Pro","MD: Vitreous/aqueous humour replacement medium, intraoperative","37284, 37758","all lots",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240906_34"
Vk_20240731_26,2024-08-14,2024-09-13,,"Semeda GmbH","ALFA-Flex and BETA-Flex Brace","MD: Ankle-foot orthosis",,"all devices delivered in the last 3 years",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240731_26"
Vk_20240906_05,2024-09-11,2024-09-11,,"Cefaly Technology","Cefaly Enhanced","MD: Tens System Electrodes",10606,,"6C06DA339415800251 to 6C06DA339415800500",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240906_05"
Vk_20240411_11,2024-04-16,2024-09-10,"additional item and lot number in scope","Smiths Medical ASD, Inc.","Portex Blue Line Siliconised PVC Tracheotomy Tube","MD: Tracheostomy tube, non-reinforced, non-customized, single-use","100/506/040, 100/506/045, 100/506/050","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240411_11"
Vk_20240829_20,2024-09-04,2024-09-10,"Added new language","DH Healthcare GmbH","DeepUnity Diagnost","MD: Picture Archiving And Communication Systems","see FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240829_20"
Vk_20240906_17,2024-09-10,2024-09-10,,"Boston Scientific Corporation","AVVIGO+ Multi-Modality Guidance System","MD: Cardiovascular ultrasound imaging system","See FSN","See FSN",,3.0.1,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240906_17"
Vk_20240909_16,2024-09-10,2024-09-10,,"Gyrus ACMI Inc.","Soltive Laser System","MD: General/multiple surgical solid-state laser system","TFL-SLS, TFL-PLS",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240909_16"
Vk_20240906_21,2024-09-10,2024-09-10,,"Shimadzu Corporation","SIL-40C X3 CL","IVD: High performance liquid chromatography analyser IVD","SIL-40C X3 CL; 228-65120-55",,L2C306051006,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240906_21"
Vk_20240906_21,2024-09-10,2024-09-10,,"Shimadzu Corporation","SIL-40C XR CL","IVD: High performance liquid chromatography analyser IVD",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240906_21"
Vk_20240910_03,2024-09-10,2024-09-10,,"DEHAS Medical Systems GmbH","QualityFlow flow meter","MD: Medical gas flowmeter, Thorpe tube",DIN-connector,"see FSN","see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240910_03"
Vk_20240910_03,2024-09-10,2024-09-10,,"DEHAS Medical Systems GmbH","Quality Mix Flowmeter","MD: Medical gas flowmeter, Thorpe tube","O2 3, 2-32 LPM","see FSN","see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240910_03"
Vk_20240905_19,2024-09-10,2024-09-10,,"Fritz Stephan GmbH","Ventilator, Infant","MD: Ventilator, infant",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240905_19"
Vk_20240829_21,2024-09-05,2024-09-10,"Added new language","DH Healthcare GmbH","DeepUnity Viewer 2.x","MD: Picture Archiving And Communication Systems","See FSN","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240829_21"
Vk_20240905_26,2024-09-10,2024-09-10,,"Philips Medical Systems","IntelliVue MX400-550","MD: Multiple vital physiological parameter monitoring system, clinical","866060, 866061, 866062, 866064, 866066","Only MX400-550 devices shipped after 26-April-2024","see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240905_26"
Vk_20240829_17,2024-09-08,2024-09-08,,"Qualigen, Inc.","FastPack TSH Calibrator Kit","IVD: Hormones/Standards Calibrators","25000024; 25000024",2405017-1,n/a,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240829_17"
Vk_20240729_01,2024-08-05,2024-09-06,Modification,"Abiomed Inc.","Impella 5.5 SmartAssist Heart Pump","MD: Intracardiac circulatory assist axial-pump catheter","0550-0007; 2000193; 2000154.; 0550-0002; 1000482; 0048-0014.","see FSN","see FSN","see FSN","https://fsca.swissmedic.ch/mep/#?q=Vk_20240729_01"
Vk_20240729_01,2024-08-05,2024-09-06,Modification,"Abiomed Inc.","Impella CP SmartAssist","MD: Intracardiac circulatory assist axial-pump catheter","0550-0007; 2000193; 2000154.; 0550-0002; 1000482; 0048-0014.","see FSN","see FSN","see FSN","https://fsca.swissmedic.ch/mep/#?q=Vk_20240729_01"
Vk_20240826_09,2024-09-06,2024-09-06,,"CODAN ARGUS AG","CODAN ARGUS 718 V","MD: Bedside infusion pump, single-channel",601349,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240826_09"
Vk_20240826_09,2024-09-06,2024-09-06,,"CODAN ARGUS AG","CODAN ARGUS 717 V","MD: Bedside infusion pump, single-channel",601268,,all,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240826_09"
Vk_20240902_14,2024-09-06,2024-09-06,,"Smiths Medical ASD, Inc.","CADD Medication Cassette Reservoir","MD: Infusion pump cassette","21-7001-24, 21-7002-24, 21-7301-24, 21-7302-24","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240902_14"
Vk_20240828_27,2024-08-29,2024-09-05,,"Abbott Ireland Diagnostic Division","Alinity i HBsAg Controls","IVD: Hepatitis B virus surface antigen IVD, control",08P0810,59044FZ00,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240828_27"
Vk_20240828_27,2024-08-29,2024-09-05,,"Abbott Ireland Diagnostic Division","ARCHITECT HBsAg Controls","IVD: Hepatitis B virus surface antigen IVD, control",6C36-10,"60109FZ00, 59039FZ00",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240828_27"
Vk_20240830_14,2024-09-05,2024-09-05,,"Bohus BioTech AB","Minivisc Plus","MD: Ophthalmology, Hyaluronic Acid And Derivatives","1183, 1184","MPFX16100, MPFX17100",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240830_14"
Vk_20240827_09,2024-09-04,2024-09-04,,"GE Healthcare GmbH",ViewPoint,"MD: Radiological PACS software",,,,"v5, v6","https://fsca.swissmedic.ch/mep/#?q=Vk_20240827_09"
Vk_20240828_28,2024-09-03,2024-09-03,,"Medtronic Navigation Inc.","Software App 9735762 Stealth S8 Application","MD: Multi-purpose stereotactic surgery system",9735762,,All,"1.3.0 and 1.3.2","https://fsca.swissmedic.ch/mep/#?q=Vk_20240828_28"
Vk_20240828_29,2024-09-03,2024-09-03,,"Paradigm Spine GmbH","HPS 2.0 Rod coupler","MD: Spinal dynamic-stabilization system",HBI92527,"1321000344, 1321000352, 1322000026, 1322000072, 1322000073, 1322000074, 1322000075",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240828_29"
Vk_20240827_11,2024-09-03,2024-09-03,,"Siemens Healthcare Diagnostics Inc.","ADVIA Centaur anti-TPO (aTPO) Assay anti-TPO (aTPO) Assay","IVD: Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, chemiluminescent immunoassay","10630886 (100T), 10630887 (500T)","26053337, 26054337, 26051337, 26052337",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240827_11"
Vk_20240827_11,2024-09-03,2024-09-03,,"Siemens Healthcare Diagnostics Inc.","Atellica IM Anti-Thyroid Peroxidase (aTPO) Assay","IVD: Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, chemiluminescent immunoassay","10995466 (100T), 10995467 (500T)","26098336, 26099336",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240827_11"
Vk_20240828_24,2024-09-03,2024-09-03,,"BIOTRH s.r.o","Los Deline","MD: Dermal tissue reconstructive material, synthetic polymer, bioabsorbable","Los Deline 100g","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240828_24"
Vk_20240830_10,2024-09-03,2024-09-03,,"Immunotech S.A.S.","Access TSH (3rd IS) reagent pack","IVD: Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay",C28643,"339117, 338724, 439341, 338367, 338057, 234251",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240830_10"
Vk_20240902_18,2024-09-03,2024-09-03,,"Philips Medical Systems Nederland B.V.","Ingenia with Evolution Upgrade","MD: Full-body MRI system, superconducting magnet","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240902_18"
Vk_20240902_18,2024-09-03,2024-09-03,,"Philips Medical Systems Nederland B.V.","Ingenia 1.5T and 3.0T","MD: Full-body MRI system, superconducting magnet","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240902_18"
Vk_20240902_18,2024-09-03,2024-09-03,,"Philips Medical Systems Nederland B.V.","Ingenia Ambition S","MD: Full-body MRI system, superconducting magnet","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240902_18"
Vk_20240902_18,2024-09-03,2024-09-03,,"Philips Medical Systems Nederland B.V.","Ingenia Ambition X","MD: Full-body MRI system, superconducting magnet","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240902_18"
Vk_20240902_18,2024-09-03,2024-09-03,,"Philips Medical Systems Nederland B.V.","Philips Ingenia Elition","MD: Full-body MRI system, superconducting magnet","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240902_18"
Vk_20240902_18,2024-09-03,2024-09-03,,"Philips Medical Systems Nederland B.V.","Ingenia & SmartPath to dStream MRI","MD: Full-body MRI system, superconducting magnet","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240902_18"
Vk_20240902_18,2024-09-03,2024-09-03,,"Philips Medical Systems Nederland B.V.","MR 5300","MD: Full-body MRI system, superconducting magnet","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240902_18"
Vk_20240902_18,2024-09-03,2024-09-03,,"Philips Medical Systems Nederland B.V.","MR 7700","MD: Full-body MRI system, superconducting magnet","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240902_18"
Vk_20240902_18,2024-09-03,2024-09-03,,"Philips Medical Systems Nederland B.V.","SmartPath to Ingenia Elition X","MD: Full-body MRI system, superconducting magnet","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240902_18"
Vk_20240902_05,2024-09-03,2024-09-03,"Added new language","Miltenyi Biotec B.V. & Co. KG","LIFE 21 apheresis unit","MD: Apheresis system","330-000-621, 330-000-622",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240902_05"
Vk_20240902_19,2024-09-03,2024-09-03,,"Waldemar Link GmbH & Co. KG","Universal Handle, Stainless Steel, straight","MD: Surgical instrument handle, non-torque-limiting",130-394/01,"C204156, C204157, C204158, C208135, C208136, C219063, C219064, C233031, C233033, C233034, C332135, C332136, C332137, C335006",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240902_19"
Vk_20240826_32,2024-09-02,2024-09-02,,"Emo-Flüssigkeit A.G.","SQUID 3ML kit","MD: Embolization implant kit","See FSN","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240826_32"
Vk_20240726_35,2024-07-30,2024-08-30,"Additional Actions, Software Update mandatory","CareDx Pty Ltd","AlloSeq HCT Software","IVD: Post bone-marrow transplant engraftment study IVD, kit, nucleic acid technique (NAT)",ASHCTS2,,,"v2.2.0, v2.2.1","https://fsca.swissmedic.ch/mep/#?q=Vk_20240726_35"
Vk_20240813_23,2024-08-20,2024-08-30,"Added new language","Smith & Nephew, Inc.","REGENETEN TENDON ANCHORS","MD: Soft-tissue/mesh anchor, bioabsorbable","72205201, 2504-1","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240813_23"
Vk_20240819_04,2024-08-20,2024-08-30,"Added new language","The Surgical Company International B.V.","Fluido Trauma set/ Fluido Standard set","MD: Radiation blood/fluid warmer intravenous set",671500/671200,"all non-expired devices",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240819_04"
Vk_20240820_22,2024-08-29,2024-08-29,,"Medtronic Inc.","Vanta with AdaptiveStim Technology Primary cell neurostimulator","AIMD: Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable",977006,,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240820_22"
Vk_20240820_23,2024-08-28,2024-08-28,,"Siemens Medical Solutions USA Inc.","ACUSON Redwood ultrasound system","MD: General-purpose ultrasound imaging system",11503314,,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240820_23"
Vk_20240821_09,2024-08-28,2024-08-28,,"Siemens Medical Solutions USA Inc.","ACUSON Maple/Maple Select ultrasound system","MD: General-purpose ultrasound imaging system","11711750, 11711779",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240821_09"
Vk_20240820_06,2024-08-28,2024-08-28,,"GS Elektromedizinische Geräte G. Stemple GmbH","Battery corpuls cpr (LiPo)","MD: Secondary battery","09120 / 09120",,"150000207 to 241500195","all, including 1.4-005","https://fsca.swissmedic.ch/mep/#?q=Vk_20240820_06"
Vk_20240827_01,2024-08-28,2024-08-28,,"Philips Medical Systems Nederland B.V.",Azurion,"MD: Stationary angiographic x-ray system, digital","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240827_01"
Vk_20240827_01,2024-08-28,2024-08-28,,"Philips Medical Systems Nederland B.V.","Allura Xper","MD: Stationary general-purpose fluoroscopic x-ray system, analogue","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240827_01"
Vk_20240827_01,2024-08-28,2024-08-28,,"Philips Medical Systems Nederland B.V.",Integris,"MD: Stationary general-purpose fluoroscopic x-ray system, digital","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240827_01"
Vk_20240827_01,2024-08-28,2024-08-28,,"Philips Medical Systems Nederland B.V.","Multi Diagnost Eleva","MD: Stationary general-purpose fluoroscopic x-ray system, analogue","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240827_01"
Vk_20240820_24,2024-08-28,2024-08-28,,"Siemens Healthcare Diagnostics Manufacturing Limited","Atellica CH Microalbumin_2 (microALB_2) Reagents","IVD: Microalbumin IVD, kit, nephelometry/turbidimetry",11097610,"232033, 232128, 232137, 232146, 232147, 242149, 242150, 242365",N/A,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240820_24"
Vk_20240820_24,2024-08-28,2024-08-28,,"Siemens Healthcare Diagnostics Manufacturing Limited","ADVIA Chemistry Microalbumin_2 (microALB_2) Reagents","IVD: Microalbumin IVD, kit, nephelometry/turbidimetry",10318197,"612528, 616644, 620971, 623768, 636498, 640513, 658356, 668872",N/A,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240820_24"
Vk_20240822_01,2024-08-27,2024-08-27,,"Dominion Biologicals Limited","NOVACLONE Anti-D IgM + IgG Monoclonal Blend","IVD: Rhesus Typing",0066037,517279,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240822_01"
Vk_20240814_07,2024-08-27,2024-08-27,,"Alcon Laboratories, Inc.","DAILIES Total 1","MD: Soft corrective contact lens, daily-disposable",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240814_07"
Vk_20240814_07,2024-08-27,2024-08-27,,"Alcon Laboratories, Inc.","TOTAL30 soft","MD: Contact Lenses",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240814_07"
Vk_20240819_08,2024-08-23,2024-08-23,,"bioMérieux SA","VIDAS CK-MB","IVD: Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)",30421,1010473720,N/A,N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240819_08"
Vk_20240730_11,2024-08-21,2024-08-21,,"GE Hualun Medical Systems Co Ltd","Proteus XR/a","MD: Vascular spatula",,,all,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240730_11"
Vk_20240813_11,2024-08-20,2024-08-20,,"MAQUET Cardiopulmonary GmbH","Serial interface cable (RS232)","MD: Cardiopulmonary bypass system, roller type","701075475; 701075475","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240813_11"
Vk_20240813_17,2024-08-20,2024-08-20,,"bioMérieux SA","VIDAS DENGUE NS1 Ag","IVD: Dengue virus antigen IVD, kit, enzyme immunoassay (EIA)",423077,"1010311970, 1010360350, 1010360380, 1010449760, 1010550540, 1010652000, 1010696870, 1010772810",N/A,N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240813_17"
Vk_20240819_24,2024-08-20,2024-08-20,,"DH Healthcare GmbH","DeepUnity Diagnost","MD: Picture Archiving And Communication Systems",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240819_24"
Vk_20240819_26,2024-08-20,2024-08-20,,"DH Healthcare GmbH","DeepUnity Viewer 2.x","MD: Picture Archiving And Communication Systems",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240819_26"
Vk_20240808_14,2024-08-13,2024-08-20,,"MAQUET Cardiopulmonary GmbH","S 0283#Kardioplegie-Set","MD: Cardiopulmonary bypass system blood tubing set",701005342,"3000302064, 3000355945",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240808_14"
Vk_20240814_22,2024-08-20,2024-08-20,,"Olympus Medical Systems Corp.","HIGH FLOW INSUFFLATION UNIT","MD: Laparoscopic insufflator","Model: UHI-4; Catalogue: N3829650, N3829660, N3829670",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240814_22"
Vk_20240812_22,2024-08-13,2024-08-19,"Added new language","DiaSorin Inc","LIAISON Testosterone xt","IVD: Total testosterone IVD, kit, chemiluminescent immunoassay",318410,"136248, 136663, 136663A, 136842, 136981, 136981A, 136981B",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240812_22"
Vk_20240812_09,2024-08-19,2024-08-19,,"Smiths Medical ASD, Inc.","BLUSelect, BLUgriggs and BLUperc Trach products","MD: Tracheostomy tube, non-reinforced, non-customized, single-use","see FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240812_09"
Vk_20240430_19,2024-05-08,2024-08-19,"Catalogue Numbers exemplified","Alcon Laboratories, Inc.","20G MVR+ V-Lance Ophthalmic knife","MD: Ophthalmic knife, single-use","see attached","see attached",,N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240430_19"
Vk_20240430_19,2024-05-08,2024-08-19,"Catalogue Numbers exemplified","Alcon Laboratories, Inc.","ClearCut knive","MD: Ophthalmic knife, single-use","see attached; see attached","see attached",N/A,N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240430_19"
Vk_20240726_29,2024-07-30,2024-08-19,"case settled, no devices on the market","Contract Medical International GmbH","Blueflow Venous Stent devices","MD: Venous endovascular stent-graft","FG-02234-004A; VS14150",900066,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240726_29"
Vk_20240816_08,2024-08-16,2024-08-16,,"Diagnostic Grifols SA","Erytra Eflexis","IVD: Blood group/antibody screening analyser IVD",210600,,,"from 1.2.0 to 3.1.0 (included)","https://fsca.swissmedic.ch/mep/#?q=Vk_20240816_08"
Vk_20240807_22,2024-08-16,2024-08-16,,"Becton, Dickinson and Company, BD Biosciences","BD FACSDuet Premium Sample Preparation System","IVD: Autosamplers","666339, 662588",,"All serial numbers with BD FACSDuet software version 1.4.1",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240807_22"
Vk_20240812_20,2024-08-15,2024-08-15,,"Unintech GmbH",Stirnfräser,"MD: Orthopaedic instrument cleaning tool",UNT-III-177588,2301,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240812_20"
Vk_20240808_18,2024-08-14,2024-08-14,,"DH Healthcare GmbH","ORBIS Medication 3.x","MD: General Medicine Instruments - Other",,,,03.19.x,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240808_18"
Vk_20240703_04,2024-07-03,2024-08-14,"additional devices affected","Bauerfeind AG",VenoTrain,"MD: Single-chamber venous compression system garment, reusable","See FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240703_04"
Vk_20240703_04,2024-07-03,2024-08-14,"additional devices affected","Bauerfeind AG",LumboTrain,"MD: Lumbar spine orthosis","See FSN","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240703_04"
Vk_20240703_04,2024-07-03,2024-08-14,"additional devices affected","Bauerfeind AG",GenuTrain,"MD: Knee support orthosis","see FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240703_04"
Vk_20240703_04,2024-07-03,2024-08-14,"additional devices affected","Bauerfeind AG","Sports Compression Ankle Support","MD: Ankle/foot orthosis","See FSN","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240703_04"
Vk_20240703_04,2024-07-03,2024-08-14,"additional devices affected","Bauerfeind AG",OmoTrain,"MD: Shoulder immobilizer/orthosis, reusable","See FSN","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240703_04"
Vk_20240711_12,2024-07-16,2024-08-14,"Added new language","Ecolab Deutschland GmbH","Olympus EndoDis Pro","MD: Disinfectants, Antiseptics, Sterilising Agents And Detergents For Medical Devices - Other","3099120, WD00342A; 3100780, WD00347A","2243AP0104, 5233AP0204, 3293AP0104, 3293AP0204, 2034AP0204",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240711_12"
Vk_20240220_02,2024-03-05,2024-08-14,"Distribution of updated IFU expected date changed","Abiomed Inc.","Impella CP","MD: Intracardiac circulatory assist axial-pump catheter","0048-0008; 0048-0002",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240220_02"
Vk_20240220_02,2024-03-05,2024-08-14,"Distribution of updated IFU expected date changed","Abiomed Inc.","Impella 5.5 SmartAssist Heart Pump","MD: Intracardiac circulatory assist axial-pump catheter","0550-0007, 2000193; 0550-0002, 1000482",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240220_02"
Vk_20240220_02,2024-03-05,2024-08-14,"Distribution of updated IFU expected date changed","Abiomed Inc.","Impella 5.0 Heart Pump","MD: Intracardiac circulatory assist axial-pump catheter","0046-3114; 005060",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240220_02"
Vk_20240220_02,2024-03-05,2024-08-14,"Distribution of updated IFU expected date changed","Abiomed Inc.","Impella LD","MD: Intracardiac circulatory assist axial-pump catheter","004681; 005080",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240220_02"
Vk_20240220_02,2024-03-05,2024-08-14,"Distribution of updated IFU expected date changed","Abiomed Inc.","Impella CP SmartAssist","MD: Intracardiac circulatory assist axial-pump catheter","2000154; 0048-0014",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240220_02"
Vk_20240220_02,2024-03-05,2024-08-14,"Distribution of updated IFU expected date changed","Abiomed Inc.","Impella 2.5","MD: Intracardiac circulatory assist axial-pump catheter","0046-3061; 005040",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240220_02"
Vk_20240220_02,2024-03-05,2024-08-14,"Distribution of updated IFU expected date changed","Abiomed Inc.","Impella RP","MD: Intracardiac circulatory assist axial-pump catheter","0046-3107; 0046-0011",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240220_02"
Vk_20240807_14,2024-08-13,2024-08-13,,"GE Healthcare","Centricity Universal Viewer Zero Footprint Client","MD: Medical image management system",,,,"v6.0 SP9.x through SP10.x","https://fsca.swissmedic.ch/mep/#?q=Vk_20240807_14"
Vk_20240813_01,2024-08-13,2024-08-13,,"Philips Medical Systems Nederland B.V.","Philips Azurion system","MD: Stationary general-purpose fluoroscopic x-ray system, analogue","722079, 722224; ",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240813_01"
Vk_20240807_19,2024-08-13,2024-08-13,,"Össur hf.","Miami J Select Collar set","MD: Cervical spine collar, reusable",MJSR-101,"MX220516 to MX230104",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240807_19"
Vk_20240807_19,2024-08-13,2024-08-13,,"Össur hf.","Miami J Select Collar","MD: Cervical spine collar, reusable",MJS-101,"MX220516 to MX230104",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240807_19"
Vk_20240807_17,2024-08-13,2024-08-13,,"Meierhofer Medizintechnik GmbH",M-PDMS,"MD: Various Instruments To Support And Monitor Vital Signs - Medical Device Software",,,,"3.2.x, 3.3.x","https://fsca.swissmedic.ch/mep/#?q=Vk_20240807_17"
Vk_20240808_16,2024-08-13,2024-08-13,,"Nutricia Medical Devices BV","Flocare Infinity III","MD: Enteral feeding pump",621825,"plug head KRAD28H","202316612104 to 202328312208",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240808_16"
Vk_20240808_27,2024-08-13,2024-08-13,,"Boston Scientific Neuromodulation Corporation","Vercise Genus","AIMD: Deep brain electrical stimulation system","M365DB12160, M365DB12320",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240808_27"
Vk_20240626_11,2024-07-02,2024-08-12,,"Welch Allyn, Inc.","Braun PRO 6000","MD: Infrared patient thermometer, ear","06000-200, 06000-300",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240626_11"
Vk_20240802_24,2024-08-12,2024-08-12,,"Philips Goldway (Shenzhen) Industrial Inc.","Philips HeartStart Intrepid Monitor/Defibrillator","MD: Physiologic-monitoring defibrillation system",867172,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240802_24"
Vk_20240805_14,2024-08-06,2024-08-12,"Added new language","Sysmex Corporation",XF-1600,"IVD: Flow cytometry analyser IVD",AD629376,,all,"8, 9 and 10","https://fsca.swissmedic.ch/mep/#?q=Vk_20240805_14"
Vk_20240424_05,2024-08-12,2024-08-12,,"Allurion Technologies, Inc.","Allurion Device/Elipse Gastric Balloon System 10D","MD: Appetite-suppression gastric balloon",10D-CE,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240424_05"
Vk_20240725_28,2024-08-12,2024-08-12,,"mySugr GmbH","mySugr Bolus Calculator","MD: Infusion Instruments - Software Accessories",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240725_28"
Vk_20240806_20,2024-08-07,2024-08-09,"Added new language","Stryker Instruments","Precision Round, Distal Bend","MD: Cranial bur, single-use","see FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240806_20"
Vk_20240709_09,2024-07-16,2024-08-08,"Added new language","Carl Reiner GmbH","EasyConnect Adapter for 2 to 4 Lumen Jet Catheter","MD: Naso-oropharyngeal Tubes - Other",CTNI-610-400,2146,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240709_09"
Vk_20240711_20,2024-07-16,2024-08-07,"Added new language","Argon Medical Devices Inc.","TruCore II","MD: End-cut biopsy gun handpiece/needle","763114100x, 763116100X, 763116160X, 763118100X, 763118200X, 763120100X, 763120160X, 763418200X, 763418250X","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240711_20"
Vk_20240711_20,2024-07-16,2024-08-07,"Added new language","Argon Medical Devices Inc.",Biopince,"MD: End-cut biopsy gun handpiece/needle","360-1080-01, 360-1580-01, 360-2080-01, 370-1080-01, 370-1580-01","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240711_20"
Vk_20240711_20,2024-07-16,2024-08-07,"Added new language","Argon Medical Devices Inc.",BioPinceUltra,"MD: End-cut biopsy gun handpiece/needle","360-1080-02, 360-1080-03, 360-1580-02, 360-1580-03, 360-2080-02, 360-2080-03, 370-1080-02, 370-1080-03, 370-1580-02, 370-1580-03","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240711_20"
Vk_20240722_23,2024-07-23,2024-08-07,"Enduser Requirements to review previous results (DE-3, DE-4, IT-3) added, minor correction (DE-4)","Biomedical Data Solutions Limited","NAT Manager","IVD: Various General Purpose Ivd Instruments - Software Accessories ","740648, 741722, 741495, 741496, 741497, 741498, 741521",,,"1.2, 1.4","https://fsca.swissmedic.ch/mep/#?q=Vk_20240722_23"
Vk_20240805_19,2024-08-07,2024-08-07,,"Bohus BioTech AB","Minivisc Plus","MD: Eye lubricant",,MPFX09100,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240805_19"
Vk_20240719_13,2024-07-23,2024-08-06,"Added new language","ConvaTec Limited","Kaltostat Dressing","MD: Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial","1203783, 1226681, 1052788","4E05238 , 4E05398 , 4E06012",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240719_13"
Vk_20240801_22,2024-08-06,2024-08-06,,"Boston Scientific Corporation","Agile Esophageal Stent Systems","MD: Polymer-metal oesophageal stent, non-sterile","See FSN","See FSN","See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240801_22"
Vk_20240801_22,2024-08-06,2024-08-06,,"Boston Scientific Corporation","Wallflex Esophageal Stent Systems","MD: Polymer-metal oesophageal stent, non-sterile","See FSN","See FSN","See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240801_22"
Vk_20240705_07,2024-07-16,2024-08-06,"Added new language",Thuasne,"Globe-Trotter blue/grey","MD: Forearm support crutch","W2016021010, W2016022010","since 02/2021",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240705_07"
Vk_20240705_07,2024-07-16,2024-08-06,"Added new language",Thuasne,"Globe-Trotter+","MD: Forearm support crutch",W2017021006,"since 02/2021",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240705_07"
Vk_20240801_06,2024-08-06,2024-08-06,,"Siemens Healthcare Diagnostics Manufacturing Limited","Atellica CH Urinary/Cerebrospinal Fluid Protein","IVD: Total protein IVD, kit, enzyme spectrophotometry",11097543,130414,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240801_06"
Vk_20240802_02,2024-08-06,2024-08-06,,"Ortho Clinical Diagnostics","ORTHO Optix Reader","IVD: Agglutination assay digital imaging reader/analyser IVD",6842223,,,V2.0.0.2870,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240802_02"
Vk_20240726_26,2024-08-06,2024-08-06,,"Medline International France SAS","Delivery Sets","MD: General surgical procedure kit, non-medicated, single-use","see FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240726_26"
Vk_20240801_04,2024-08-06,2024-08-06,,"Siemens Healthcare Diagnostics Inc.","Atellica IM CA 19-9 Assay","IVD: Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay","10995490, 10995489","55974535, 55975535, 55977535",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240801_04"
Vk_20240801_04,2024-08-06,2024-08-06,,"Siemens Healthcare Diagnostics Inc.","ADVIA Centaur CA 19-9 Assay","IVD: Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay","10491379, 10491244","55970535, 55970535, 55971535, 55972535, 55973535",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240801_04"
Vk_20240726_02,2024-07-30,2024-08-05,"Added new language","Beckman Coulter Ireland, Inc.","IRISpec CA/CB/CC","IVD: Controls/standards/calibrators Clinical Chemistry","800-7702; 800-7211","432-24 and higher; 432-24 and higher",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240726_02"
Vk_20240723_06,2024-08-05,2024-08-05,,"Eurobio Scientific SA","EurobioPlex HEV","IVD: Hepatitis E Virus - Na Reagents","EBX-010-50, EBX-010-100","405003, 015609, 019712, 034523, 405103, 015709, 034623, EBX-010-100, 405003, 019712, 405103, 015709, 015609, 034523, 034623",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240723_06"
Vk_20220525_17,2022-06-02,2024-08-02,"Typing error in document name","Medtronic MiniMed","MiniMed 640G Insulin Pump","MD: Ambulatory insulin infusion pump, electronic","see FSN",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20220525_17"
Vk_20220525_17,2022-06-02,2024-08-02,"Typing error in document name","Medtronic MiniMed","MiniMed 670G Insulin Pump","MD: Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm","see FSN",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20220525_17"
Vk_20220525_17,2022-06-02,2024-08-02,"Typing error in document name","Medtronic MiniMed","MiniMed 720G Insulin Pump","MD: Ambulatory insulin infusion pump, electronic, non-software-dosing","see FSN",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20220525_17"
Vk_20220525_17,2022-06-02,2024-08-02,"Typing error in document name","Medtronic MiniMed","MiniMed 740G Insulin Pump","MD: Ambulatory insulin infusion pump, electronic, software-dosing, binary algorithm","see FSN",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20220525_17"
Vk_20220525_17,2022-06-02,2024-08-02,"Typing error in document name","Medtronic MiniMed","MiniMed 770G Insulin Pump","MD: Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm","see FSN",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20220525_17"
Vk_20220525_17,2022-06-02,2024-08-02,"Typing error in document name","Medtronic MiniMed","MiniMed 780G Insulin Pump","MD: Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm","see FSN",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20220525_17"
Vk_20240628_34,2024-07-02,2024-08-02,"Added new language","Shenzhen Med-Link Elelctronics Tech Co.,LTD.","SPO2 Sensor","MD: Pulse oximeter, line-powered","S0026M-L; S0190M-LP",JA20230610008,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240628_34"
Vk_20240715_22,2024-07-31,2024-07-31,,"Philips Respironics, Inc","Trilogy Evo O2","MD: Portable electric ventilator","All (see FSN)","All (see FSN)","All (see FSN)","see FSN","https://fsca.swissmedic.ch/mep/#?q=Vk_20240715_22"
Vk_20240715_22,2024-07-31,2024-07-31,,"Philips Respironics, Inc","Trilogy EV300","MD: Portable electric ventilator","All (see FSN)","All (see FSN)","All (see FSN)","see FSN","https://fsca.swissmedic.ch/mep/#?q=Vk_20240715_22"
Vk_20240715_22,2024-07-31,2024-07-31,,"Philips Respironics, Inc","Trilogy Evo","MD: Portable electric ventilator","All (see FSN)","All (see FSN)","All (see FSN)","see FSN","https://fsca.swissmedic.ch/mep/#?q=Vk_20240715_22"
Vk_20240729_53,2024-07-30,2024-07-30,,"Löwenstein Medical Technology GmbH + Co. KG","LUISA (LM150TD)","MD: Portable electric ventilator",,,all,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240729_53"
Vk_20240729_53,2024-07-30,2024-07-30,,"Löwenstein Medical Technology GmbH + Co. KG","TIVAN LS","MD: Portable electric ventilator",,,all,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240729_53"
Vk_20240729_53,2024-07-30,2024-07-30,,"Löwenstein Medical Technology GmbH + Co. KG","Life One","MD: Portable electric ventilator",,,all,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240729_53"
Vk_20240711_03,2024-07-30,2024-07-30,,"HumanOptics Holding AG","IOL models in ""Safeloader"" (SL) packaging (Aspira-aA, Aspira-aA, Aspira-aAY, Aspira-aAY, Diff-aA, Diff-aAY, Aspira-aXAY, Aspira-aXA, Triva-aAY)","MD: Intraocular lens, Posterior Chamber, Hydrophilic Acrylic (different models with the same packaging type (SL))","00084453, 00087450, 00084353, 00087350, 00085150, 00085250, 00087550, 00087950, 00088650",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240711_03"
Vk_20240730_02,2024-07-30,2024-07-30,,"Andersen Caledonia","SP Eye Sharps Safe Intravitreal Injection Needle","MD: Ophthalmic needle, single-use","SPY 712",N011169,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240730_02"
Vk_20240718_30,2024-07-30,2024-07-30,,"Life Vascular Devices Biotech, S.L.","iVascular sergeant","MD: Peripheral vascular catheter","DSPC18065001, DSPC18090001, DSPC18130001, DSPC18150001, DSPC18065002, DSPC18090002, DSPC18130002, DSPC18150002",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240718_30"
Vk_20240723_27,2024-07-30,2024-07-30,,"Schiller AG","CARDIOVIT AT-180","MD: Electrocardiograph, professional, multichannel","3.920570 / 0A.110000","N/A not lot/batch number related","N/A not serial number related","All software versions","https://fsca.swissmedic.ch/mep/#?q=Vk_20240723_27"
Vk_20240724_12,2024-07-24,2024-07-29,"Added new language","Abbott Medical","HeartMate 3 System Controller","AIMD: Implantable ventricular circulatory assist system control unit","106524INT, 106531INT, 106531LF2",,"Specific serial numbers of the HeartMate3 LVAS kit (model: 106524INT) and the HeartMate 3 System Controller (model: 106531INT, 106531LF2) distributed since March 2024.",N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240724_12"
Vk_20240711_21,2024-07-29,2024-07-29,,"AI DE Diagnostic Co., LDT","Primeview HCG mini","IVD: HCG pregnancy test",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240711_21"
Vk_20231025_18,2023-11-01,2024-07-29,,"Philips Electronics Nederland B.V.","Philips Intera, Achieva, Ingenia CX","MD: Full-body MRI system, superconducting magnet","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20231025_18"
Vk_20240611_17,2024-07-29,2024-07-29,,"Beckman Coulter , Inc.","Access HBc Ab Reagent","IVD: Hepatitis B Core Antibody (total)",34240,"see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240611_17"
Vk_20240310_11,2024-07-29,2024-07-29,,"DT MedTech LLC","Hintermann Series H3 Total Ankle Replacement (TAR) System","MD: Coated ankle tibia prosthesis","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240310_11"
Vk_20240626_21,2024-06-27,2024-07-26,"Added new language","Shenzhen Besdata Technology Co., Ltd","Automated External Defibrillator","MD: Non-rechargeable public automated external defibrillator","BeneHeart C1A; BeneHeart C2",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240626_21"
Vk_20240716_24,2024-07-25,2024-07-25,,"Beckman Coulter , Inc.","DxI 9000 Access Immunoassay Analyzer","IVD: Chemiluminescent immunoassay analyser IVD",C11137,,"Please refer to the FSN 24041 letter.",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240716_24"
Vk_20240701_15,2024-07-02,2024-07-24,"additional information","HumanTech Germany",Venus,"MD: Bone-screw internal spinal fixation system, sterile","VL-RC-5-4, VL-RC-5-5, VL-RC-5-6, VL-RC-5-7, VL-RC-5-8, VL-RS-5-4, VL-RS-5-5, VL-RS-5-9","H1246QJ, H1305QK, H1330QJ, H1137QJ, H1409QI, H1222QJ, H1325QI, H1324QI, H1327QI",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240701_15"
Vk_20240527_15,2024-05-27,2024-07-23,,"tecfor care GmbH","Ecofit Xtra 120","MD: Electrical assistive bed","see FSN",,"all serial number from 21 0000000000, to 23 9999999999",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240527_15"
Vk_20240527_15,2024-05-27,2024-07-23,,"tecfor care GmbH","Ecofit Xtra 140","MD: Electrical assistive bed","see FSN",,"all serial number from 21 0000000000, to 23 9999999999",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240527_15"
Vk_20240704_16,2024-07-11,2024-07-23,"Added new language","Biokit S.A.","Alinity c Proteins Standard","IVD: Plasma protein IVD, calibrator","3029-2128 (O8P67-01)",01594L823,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240704_16"
Vk_20240704_01,2024-07-11,2024-07-23,"Added new language","Ventana Medical Systems, Inc","VENTANA anti-CD10 (SP67) Rabbit Monoclonal Primary","IVD: Primary Antisera For Immunohistology",05857856001,"J04613, J11853, J17541, J25047, J30286, K00982, K06239, K09880, K14266, K19784, K26461, M00669",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240704_01"
Vk_20240717_21,2024-07-23,2024-07-23,,"Boston Scientific Neuromodulation Corporation","WaveWriter Alpha","AIMD: Analgesic spinal cord electrical stimulation system","SC-1216 and SC-1232",,"WAVEWRITER ALPHA 16 IPG KIT: 100188 to 758920; WAVEWRITER ALPHA 32 IPG KIT: 100635 to 759404",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240717_21"
Vk_20240717_17,2024-07-23,2024-07-23,,"Leonhard Lang GmbH","corPatch easy pediatric","MD: Multifunction cardiac electrode, paediatric",,"see attached FSN",,05120.3,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240717_17"
Vk_20240717_17,2024-07-23,2024-07-23,,"Leonhard Lang GmbH","corPatch easy","MD: Multifunction cardiac electrode, adult",,"see attached FSN",,04324.3,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240717_17"
Vk_20240717_17,2024-07-23,2024-07-23,,"Leonhard Lang GmbH","corPatch easy pre-connected","MD: Multifunction cardiac electrode, adult",,"see attached FSN",,05120.1,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240717_17"
Vk_20240716_22,2024-07-23,2024-07-23,,"Bausch & Lomb GmbH","Corneal Irrigator","MD: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use","82020S; 82020S","Lots from Juli 2023 to November 2023 were affected (see attached Locator list)",N/A,N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240716_22"
Vk_20240506_21,2024-05-17,2024-07-23,"Additional info","tecfor care GmbH",Ecofit,"MD: Electrical assistive bed","see FSN",,"all serial numbers from 21 0000000000 to 23 9999999999",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240506_21"
Vk_20240722_16,2024-07-23,2024-07-23,,"Dräger Safety AG & Co. KGaA","Alcotest 7000 charging cradle","MD: Analyzers, Point-of-Care, Breath, Alcohol","3700420 (3700399)",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240722_16"
Vk_20240711_13,2024-07-23,2024-07-23,,"Ziehm Imaging GmbH","Ziehm 8000","MD: C-arm, diagnostic x-ray unit, mobile",,,82975,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240711_13"
Vk_20240711_13,2024-07-23,2024-07-23,,"Ziehm Imaging GmbH","Ziehm Solo","MD: Radiographic/fluoroscopic unit, general-purpose",,,"55237, 55252, 55182, 55140, 54973, 54955, 54927, 55064",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240711_13"
Vk_20240711_13,2024-07-23,2024-07-23,,"Ziehm Imaging GmbH","Ziehm Solo FD","MD: Various Instruments For Radiodiagnostics And Interventional Procedures",,,"55277, 55203, 55196, 55113, 55092, 55045, 55042, 55041, 55035, 55018, 54984, 54905, 54835",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240711_13"
Vk_20240711_13,2024-07-23,2024-07-23,,"Ziehm Imaging GmbH","Ziehm Vision RFD 3D","MD: Mobile general-purpose fluoroscopic x-ray system, digital",,,"23388, 23387, 23371",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240711_13"
Vk_20240711_13,2024-07-23,2024-07-23,,"Ziehm Imaging GmbH","Ziehm Vision FD","MD: Various Instruments For Radiodiagnostics And Interventional Procedures",,,"93634, 93633, 93632, 93596, 93592, 93551, 93550, 93549, 93548, 93546, 93545, 93537, 93450, 93449, 93448, 93436",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240711_13"
Vk_20240711_13,2024-07-23,2024-07-23,,"Ziehm Imaging GmbH","Ziehm Compact","MD: Basic diagnostic x-ray system",,,80374,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240711_13"
Vk_20240719_01,2024-07-23,2024-07-23,,"RAL Diagnostics","RAL Diff-Quik Fixative solution","IVD: Haematology Stains For Microscopy - Other",720560-2500,M76234,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240719_01"
Vk_20240723_05,2024-07-23,2024-07-23,,"Beckman Coulter Ireland, Inc.","IRISpec CA/CB/CC","IVD: Controls/standards/calibrators Clinical Chemistry",800-7702,"Lot 432-24 and higher.",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240723_05"
Vk_20240704_02,2024-07-09,2024-07-22,"Updated FSN","D-tek SA","NDH Chromatin + DFS70 DOT for BDI","IVD: Autoimmune Disease Tdm",AD-NDHDFSDBD,FA240518,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240704_02"
Vk_20240703_37,2024-07-22,2024-07-22,,"Baxter Medical Systems GmbH + Co. KG","Präzisionschirurgietisch PST 500 U","MD: Universal operating table, electromechanical",4080100,00887761973466,"See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240703_37"
Vk_20240712_19,2024-07-16,2024-07-22,"Added new language","Bruker Daltonics GmbH & Co. KG","UMIC Colistin","IVD: Antibacterial minimum inhibitory concentration (MIC) IVD",UM-COL-040,"240410COL, 240418COL, 240506COL",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240712_19"
Vk_20221213_23,2023-01-10,2024-07-19,"additional lots identified","Smiths Medical ASD, Inc.","Administration sets used with CADD pumps","MD: Electric infusion pump administration set, single-use","See FSN","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20221213_23"
Vk_20221213_23,2023-01-10,2024-07-19,"additional lots identified","Smiths Medical ASD, Inc.","Medication cassette reservoirs with Flow Stop","MD: Infusion pump cassette","See FSN","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20221213_23"
Vk_20240710_35,2024-07-11,2024-07-19,"Added new language","Medtronic Inc.","CareLink Programmer","AIMD: Cardiac pulse generator programmer",2090,,"All with prefixes PKK0 and PKK1","3.2 or higher","https://fsca.swissmedic.ch/mep/#?q=Vk_20240710_35"
Vk_20240715_28,2024-07-19,2024-07-19,,"Becton, Dickinson and Company","BD BACTEC MGIT 960 PZA Kit","IVD: Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit","See FSN","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240715_28"
Vk_20240620_28,2024-07-10,2024-07-18,"follow up FSN about installation of the safety kit","CAPRON PODOLOGIE","Chairs F1 2000, F1 2000 Ergo, F1 Neo, F1 Neo Ergo, F1 3000, F1 3000 Ergo","MD: Electric Medical Chairs - Other","see FSN",,"All Serial numbers are involved",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240620_28"
Vk_20240711_02,2024-07-11,2024-07-18,"Added new language","MAQUET Cardiopulmonary GmbH","all Maquet Cardiopulmonary GmbH products containing the component vacuum-tight reservoir (VHK 71000)","MD: Reservoir used to collect, store and filter blood for up to six hours in the extracorporeal circuit during cardiopulmonary bypass operations on adult patients, with or without vacuum-assisted venous return.","two variations: Stand-Alone reservoir (VHK-Reservoir) or Integrated with Oxygenators (VKMO) - see FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240711_02"
Vk_20240625_21,2024-07-15,2024-07-17,"Added new language","Medivance, Inc.","Arctic Sun Temperature Management System","MD: External circulating-fluid core temperature regulation system control unit, heating/cooling","See FSN",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240625_21"
Vk_20230510_21,2023-05-16,2024-07-17,"Added new language","Medtronic Inc.",Cobalt,"AIMD: Cardiac resynchronization therapy implantable defibrillator",,,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20230510_21"
Vk_20230510_21,2023-05-16,2024-07-17,"Added new language","Medtronic Inc.","Claria MRI / Amplia MRI / Compia MRI / Viva / Brava CRT-Ds","AIMD: Cardiac resynchronization therapy implantable defibrillator",,,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20230510_21"
Vk_20230510_21,2023-05-16,2024-07-17,"Added new language","Medtronic Inc.","Cobalt XT","AIMD: Dual-chamber implantable defibrillator",,,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20230510_21"
Vk_20230510_21,2023-05-16,2024-07-17,"Added new language","Medtronic Inc.",Crome,"AIMD: Cardiac resynchronization therapy implantable defibrillator",,,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20230510_21"
Vk_20230510_21,2023-05-16,2024-07-17,"Added new language","Medtronic Inc.","Visia AF / Visia AF MRI / Evera / Evera MRI ICDs","AIMD: Single-chamber / Dual-chamber implantable defibrillator",,,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20230510_21"
Vk_20230510_21,2023-05-16,2024-07-17,"Added new language","Medtronic Inc.","Primo MRI ICD","AIMD: Single-chamber / Dual-chamber implantable defibrillator",,,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20230510_21"
Vk_20230510_21,2023-05-16,2024-07-17,"Added new language","Medtronic Inc.","Mirro MRI ICD","AIMD: Single-chamber / Dual-chamber implantable defibrillator",,,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20230510_21"
Vk_20240709_15,2024-07-16,2024-07-16,,"Medtronic Inc.","DLP Single Stage Venous Cannulae","MD: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage",67312,"2023090954, 202312C065",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240709_15"
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