# 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_20260527_039,2026-06-01,2026-06-01,,"Primed Halberstadt Medizintechnik GmbH","Priflex Trachealkanüle mit Cuff","MD: Tracheostomy tube, reinforced, non-customized, single-use",200815,02.09.2025,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260527_039"
Vk_20260513_047,2026-05-19,2026-06-01,"Update of section 3.4","Remel Inc","Xpect Giardia KT/20TST","IVD: Giardia lamblia antigen IVD, kit, rapid ICT, clinical",R2450020,"263838, 380753, 391368",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260513_047"
Vk_20260429_014,2026-05-18,2026-05-29,"added new language","Micromed S.p.A.","SD LTM 64 PLUS","MD: Various neurology and neurosurgery instruments - hardware accessories","SD LTM 64 PLUS; SD LTM 64 PLUS",,"see FSN",2022.01,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260429_014"
Vk_20260528_022,2026-05-29,2026-05-29,,"Thermo Fisher Scientific","YEASTONE BROTH","IVD: Fungal antimicrobial susceptibility culture medium IVD",YY3462,4539334,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260528_022"
Vk_20260522_022,2026-05-29,2026-05-29,,"RaySearch Laboratories AB publ",RayCare,"MD: Various radiotherapy and radiosurgery instruments - software accessories","See FSN",,,"See FSN","https://fsca.swissmedic.ch/mep/#?q=Vk_20260522_022"
Vk_20260511_010,2026-05-12,2026-05-29,"additional languages added","WEINMANN Emergency Medical Technology GmbH & Co. KG","MEDUMAT Standard","MD: Portable pulmonary ventilators","28710-01, 28710-02, 28710-03, 28710-04; 29300, 29500, 29350, 29550",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260511_010"
Vk_20260529_001,2026-05-29,2026-05-29,,"Löwenstein Medical Innovation GmbH & Co. KG","elisa 300, elisa 500, elisa 600, elisa 800 (VIT)","MD: Intensive care ventilator",,,"see FSN","see FSN","https://fsca.swissmedic.ch/mep/#?q=Vk_20260529_001"
Vk_20260518_074,2026-05-20,2026-05-28,"Update of measures","Bolton Medical, Inc.","RelayPro Thoracic Stent Graft System","MD: Descending thoracic aorta endovascular stent-graft","see FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260518_074"
Vk_20260521_019,2026-05-28,2026-05-28,,"Datex-Ohmeda Inc.","Giraffe OmniBed Carestation","MD: Conventional infant incubator","see FSN",,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260521_019"
Vk_20260427_026,2026-05-01,2026-05-28,"add. info for lot identification","Stryker GmbH","Hoffman 3 Chuck for Pins 3 Universal for Dia 4, 5, 6","MD: External orthopaedic fixation system noninvasive component, single-use",49229050,"see FSN",,N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260427_026"
Vk_20260526_032,2026-05-28,2026-05-28,,"Armstrong Medical Limited","Resuscitation Sets (Mapleson Systems) ","MD: APL Valve","see FSN",,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260526_032"
Vk_20260526_032,2026-05-28,2026-05-28,,"Armstrong Medical Limited","Paediatric Ayres T‑Piece Systems (Resuscitation Set)","MD: APL Valve","see FSN",,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260526_032"
Vk_20260526_032,2026-05-28,2026-05-28,,"Armstrong Medical Limited","Adult Coaxial Breathing Systems ","MD: APL Valve","see FSN",,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260526_032"
Vk_20260526_032,2026-05-28,2026-05-28,,"Armstrong Medical Limited","Positive Expiratory Pressure (PEP) Therapy Devices ","MD: APL Valve","see FSN",,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260526_032"
Vk_20260521_013,2026-05-28,2026-05-28,,"Insulet Corp.","Omnipod Insulin Management System (Eros)","MD: Portable insulin microinfusors","POD-ZXP425; ","L72509, L72513, L72509, L72511, L72513, L72514, L72515",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260521_013"
Vk_20260521_013,2026-05-28,2026-05-28,,"Insulet Corp.","Omnipod 5 Pod","MD: Portable insulin microinfusors connectable to continuous glucose monitoring systems",POD-OMNI-I1-6720,"PH1U01022521, PH1U04182521, PH1U10212421, PH1U12192411, PH1U12192421, PH1U12202421",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260521_013"
Vk_20260521_013,2026-05-28,2026-05-28,,"Insulet Corp.","Omnipod DASH Insulin Management System","MD: Ambulatory insulin infusion pump/blood glucose analyser system",POD-BLE-I1-529,"PD1U04292521, PD1U11132421, PD1U11142421, PD1U11152411, PD1U11152421, PD1U11162421, PD1U11182421",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260521_013"
Vk_20260414_037,2026-04-21,2026-05-27,"additional information","Philips Medical Systems Nederland B.V. ","Evolution Upgrade","MD: Full-body MRI system, superconducting magnet","782116, 782148, 782166, 782143, 782162",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260414_037"
Vk_20260414_037,2026-04-21,2026-05-27,"additional information","Philips Medical Systems Nederland B.V. ",Ingenia,"MD: Full-body MRI system, superconducting magnet","781315, 781341, 781396, 782115, 781262, 781342, 781377, 782103, 781271, 782105, 781359, 782108, 782139, 781356, 782109, 782138, 782160, 781357, 782106, 782137, 781358, 782107, 782136",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260414_037"
Vk_20260414_037,2026-04-21,2026-05-27,"additional information","Philips Medical Systems Nederland B.V. ","MR 7700","MD: Full-body MRI system, superconducting magnet","782120, 782153, 782130",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260414_037"
Vk_20260414_037,2026-04-21,2026-05-27,"additional information","Philips Medical Systems Nederland B.V. ","SmartPath to dStream","MD: Full-body MRI system, superconducting magnet","781260, 782112, 782145, 781270, 782113, 782118, 782144, 782163",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260414_037"
Vk_20260414_037,2026-04-21,2026-05-27,"additional information","Philips Medical Systems Nederland B.V. ",Achieva,"MD: Full-body MRI system, superconducting magnet","781178, 781196, 781296, 781278",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260414_037"
Vk_20260520_008,2026-05-27,2026-05-27,,"W. L. Gore & Associates, Inc.","GORE® TAG® Thoracic Branch Endoprosthesis","MD: Aortic arch endovascular stent-graft","see FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260520_008"
Vk_20260522_044,2026-05-27,2026-05-27,,"Boston Scientific Coorpration","CRE Wireguided Balloon Dilatation Catheter","MD: Gastrointestinal/biliary dilation balloon catheter, non-medicated","see FSN; see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260522_044"
Vk_20260519_056,2026-05-27,2026-05-27,,"Philips Medical Systems Nederland B.V. ","MultiDiagnost Eleva","MD: Stationary general-purpose fluoroscopic x-ray system, analogue","See FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260519_056"
Vk_20260519_056,2026-05-27,2026-05-27,,"Philips Medical Systems Nederland B.V. ",Allura,"MD: Stationary angiographic x-ray system, digital","See FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260519_056"
Vk_20260519_055,2026-05-27,2026-05-27,,"Medtronic Navigation Inc.","O-arm O2 Imaging System","MD: Portable general-purpose fluoroscopic x-ray system, digital","BI70002000; ",,C4074,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260519_055"
Vk_20260520_001,2026-05-27,2026-05-27,,"Bayer Medical Care Inc.","MEDRAD Avanta Multi-Patient Disposable Set","MD: High pressure extension lines","AVA 500 MPAT (Part 2 of 2)","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260520_001"
Vk_20260519_021,2026-05-27,2026-05-27,,"ICU Medical, Inc.",Chemolock,"MD: Vial/bottle adaptor, non-hermetic","011-CL3955; 011-CL3955",13542707,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260519_021"
Vk_20260520_002,2026-05-27,2026-05-27,,"Siemens Healthcare GmbH","ARTIS icono","MD: Stationary angiographic x-ray system, digital","floor, biplane, ceiling; ",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260520_002"
Vk_20260428_007,2026-05-04,2026-05-26,"Added DE & IT version","MicroVention Inc.","BOBBY Balloon Guide Catheter","MD: Intravascular occluding balloon catheter, image-guided","See FSN","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260428_007"
Vk_20260505_027,2026-05-12,2026-05-26,"add. languages","Hamilton Medical AG",IntelliCuff,"MD: Respiratory and anaesthesia devices - other",951001,,"smaller than 19732",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260505_027"
Vk_20260521_029,2026-05-26,2026-05-26,,"GE Medical Systems Information Technologies, Inc.","ApexPro CARESCAPE Telemetry Server","MD: Patient monitoring system module, electrocardiographic, telemetric",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260521_029"
Vk_20260205_027,2026-05-26,2026-05-26,"SyGan GmbH is not a manufacturer","Tianjin Plastics Research Institute Co., Ltd","Extra-corporeal circuit tube","MD: Extracorporeal and assisted circulation devices - accessories",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260205_027"
Vk_20260428_037,2026-05-11,2026-05-22,"New languages","V. Guldmann A/S","Guldmann Hoist","MD: Fixed patient lifting system, electrically-powered","GH1 F; 554125",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260428_037"
Vk_20260506_035,2026-05-21,2026-05-21,,"BÜHLMANN Laboratories AG","CAST Allergen Peanut","IVD: Allergy tests - other",BAG-F13,5147,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260506_035"
Vk_20260521_003,2026-05-21,2026-05-21,,"BD Switzerland Sàrl","BD Connecta Stopcocks","MD: Intravenous line stopcock","394501, 394600, 394601, 394602, 394605, 394926, 394936, 394945, 394951, 394961, 394971, 394982, 394983","Refer to FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260521_003"
Vk_20260513_001,2026-05-20,2026-05-20,,"Hamilton Medical AG","Breathing circuit set, coaxial","MD: Ventilator breathing circuit, single-use","260127, 260128, 260167, 2026168","Between 200379 and 205050 (inclusive)",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260513_001"
Vk_20260513_028,2026-05-20,2026-05-20,,"Covidien llc","Endoflip v1.0 System","MD: Manometric gastrointestinal motility analysis system","EF-100, RFG-EF100, DLEF-100",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260513_028"
Vk_20260513_045,2026-05-20,2026-05-20,,"Gentherm Medical LLC",Kool-Kit,"MD: External circulating-fluid core temperature regulation system control unit, heating/cooling","900, 910. 920, 930, 950","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260513_045"
Vk_20260513_045,2026-05-20,2026-05-20,,"Gentherm Medical LLC",PlastiPad,"MD: External circulating-fluid core temperature regulation system control unit, heating/cooling","193, 193CPC, 194, 194CPC, 195N, 196, 196CPC","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260513_045"
Vk_20260513_045,2026-05-20,2026-05-20,,"Gentherm Medical LLC","Maxi-Therm Lite","MD: External circulating-fluid core temperature regulation system control unit, heating/cooling","; 871, 872, 873, 874, 876, 300","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260513_045"
Vk_20260513_045,2026-05-20,2026-05-20,,"Gentherm Medical LLC",Gelli-Roll,"MD: External circulating-fluid core temperature regulation system control unit, heating/cooling","194P, 195P","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260513_045"
Vk_20260513_045,2026-05-20,2026-05-20,,"Gentherm Medical LLC","Head Wrap","MD: External circulating-fluid core temperature regulation system pad, reusable",600,"See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260513_045"
Vk_20260402_046,2026-04-17,2026-05-20,"Additional info in section on how to locate affected purge cassettes. Added new language. ","Abiomed Inc","Impella Purge Cassette","MD: Controllers - other. Accessory to intracardiac circulatory assist axial-pump.","0043-0001; 0043-0009; in Pack/Set: 0043-0002; 0043-0003; 0048-0014; 0550-0002; 0046-0011","This FSCA is applicable to all Purge cassette Generation (GEN) 1 distributed in Pump sets or as an independent item","This FSCA is applicable to all Purge cassette Generation (GEN) 1 distributed in Pump sets or as an independent item",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260402_046"
Vk_20260211_003,2026-03-09,2026-05-20,"Updated information","Philips Respironics, Inc","Trilogy Evo","MD: Portable electric ventilator","Refer to UAL (Units affected List)",,"Refer to UAL (Units affected List)",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260211_003"
Vk_20260211_003,2026-03-09,2026-05-20,"Updated information","Philips Respironics, Inc","Trilogy EV300","MD: Portable electric ventilator","Refer to UAL (Units affected List)",,"Refer to UAL (Units affected List)",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260211_003"
Vk_20260211_003,2026-03-09,2026-05-20,"Updated information","Philips Respironics, Inc","Trilogy Evo O2","MD: Portable electric ventilator","Refer to UAL (Units affected List)",,"Refer to UAL (Units affected List)",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260211_003"
Vk_20260518_067,2026-05-19,2026-05-19,,"Dexcom, Inc.","Dexcom G7 CGM","MD: Percutaneous interstitial fluid glucose monitoring system, electrochemical",STP-AT-012,"1725069002, 1725204004",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260518_067"
Vk_20250417_01,2025-04-22,2026-05-19,"New FSN, new Actions to be taken, additional affected Lots","Siemens Healthcare Diagnostics Inc.","Atellica IM Homocysteine Calibrator","IVD: Homocysteine IVD, calibrator","10995498; 10995498","86236A74, 44206A75, 25675A77, 44505A78, 52364A79",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250417_01"
Vk_20250417_01,2025-04-22,2026-05-19,"New FSN, new Actions to be taken, additional affected Lots","Siemens Healthcare Diagnostics Inc.","ADVIA Centaur HCY Calibrator","IVD: Homocysteine IVD, calibrator","10310376; 10310376","86237A74, 44207A75, 25674A77, 44506A78, 52363A79 ",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250417_01"
Vk_20260504_035,2026-05-08,2026-05-19,"list of affected batches added","ELLA-CS, s.r.o.","SX-ELLA Stent Danis (Danis stent)","MD: Polymer-metal oesophageal stent","019-08S-25-135-B; 019-08S-25-135","Listed in annex.",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260504_035"
Vk_20260518_072,2026-05-19,2026-05-19,,"EKF-diagnostic GmbH ","Chip Sensor Lactate, Type II","IVD: Lactate electrode IVD","5206-3029; 5206-3029",CL2615,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260518_072"
Vk_20260504_048,2026-05-05,2026-05-18,"Additional languages (DE, FR), Acknowledgment Form in FSN EN","Baxter Medical Systems GmbH + Co. KG","TrueSystem 7000","MD: Universal operating table, electromechanical","1739994; ",,"See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260504_048"
Vk_20260501_001,2026-05-04,2026-05-15,"additional languages added","Philips Medical Systems Nederland B.V. ",Allura,"MD: Stationary angiographic x-ray system, digital","See FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260501_001"
Vk_20260501_001,2026-05-04,2026-05-15,"additional languages added","Philips Medical Systems Nederland B.V. ",Azurion,"MD: Stationary angiographic x-ray system, digital","See FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260501_001"
Vk_20260506_006,2026-05-12,2026-05-13,"Added new language","Intuitive Surgical","da Vinci 5 Surgical System","MD: Robot-assisted endoscopic surgery systems","380746; Not applicable","Not applicable","See attachment 1","Not applicable","https://fsca.swissmedic.ch/mep/#?q=Vk_20260506_006"
Vk_20260423_001,2026-05-13,2026-05-13,,"Clinical Innovations, LLC","Kiwi Omni Vacuum Delivery System","MD: Foetal vacuum extraction system cup, single-use",VAC-6000MTE,"251652, 251597, 251485",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260423_001"
Vk_20260512_036,2026-05-13,2026-05-13,,"Abbott Medical","MERLIN PATIENT CARE SYSTEM (PCS)","MD: Cardiac pulse generator software","3650; WHEN USED WITH AVEIR™ LEADLESS SYSTEM",,"Merlin 3650 Programmer SW 3330 Versions: v25.0.X - v28.7.X","SW 3330 Versions: v25.0.X - v28.7.X","https://fsca.swissmedic.ch/mep/#?q=Vk_20260512_036"
Vk_20260513_012,2026-05-13,2026-05-13,,"Medtronic, Inc.","Octopus Evolution Tissue Stabilizer","MD: Patient positioning vacuum pad",TS2000,"in Switzerland: 0232992409; overall: 0232992409, 0233010063, 0233010115",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260513_012"
Vk_20260513_012,2026-05-13,2026-05-13,,"Medtronic, Inc.","Octopus Nuvo Tissue Stabilizer","MD: Patient positioning vacuum pad",TSMICS1,"in Switzerland: 0231792414; overall: 0231547054, 0231591827, 0231758880, 0231758898, 0231758932, 0231792414, 0231792421, 0231912903, 0232670901, 0232709219, 0232709254, 0232744928, 0232784925, 0232784989, 0232805458, 0232837110",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260513_012"
Vk_20260505_032,2026-05-12,2026-05-12,,"Elekta Solutions AB","MOSAIQ Oncology Information System","MD: Linear accelerators - software accessories",,,,"3.2.1, 3.2.2, 3.2.3 with Unity","https://fsca.swissmedic.ch/mep/#?q=Vk_20260505_032"
Vk_20260512_004,2026-05-12,2026-05-12,,"Intuitive Surgical","da Vinci SP1098 Patient Side Cart (PSC)","MD: Robotic surgical arm system","380601 / Version 50 & Higher","Not applicable","All serial numbers",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260512_004"
Vk_20260504_047,2026-05-11,2026-05-11,,"MEQU A/S","°M Warmer","MD: Conduction blood/fluid warmer","MWS201(Box of 5 °M Warmers) MWS201W (Single °M Warmer in Silver Pouch); ",,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260504_047"
Vk_20260430_029,2026-04-30,2026-05-11,"added new language","Stryker Neurovascular","InZone Detachment System","MD: Vascular implant detacher, electronic, single-use","see FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260430_029"
Vk_20250702_01,2025-07-08,2026-05-08,"new systems added","Philips Medical Systems Nederland B.V.","MR 5300","MD: Full-body MRI system, superconducting magnet","See FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250702_01"
Vk_20250702_01,2025-07-08,2026-05-08,"new systems added","Philips Medical Systems Nederland B.V.",Ingenia,"MD: Full-body MRI system, superconducting magnet","See FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250702_01"
Vk_20250702_01,2025-07-08,2026-05-08,"new systems added","Philips Medical Systems Nederland B.V.","Upgrade to MR 7700","MD: Full-body MRI system, superconducting magnet","See FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250702_01"
Vk_20250702_01,2025-07-08,2026-05-08,"new systems added","Philips Medical Systems Nederland B.V.","SmartPath to Ingenia","MD: Full-body MRI system, superconducting magnet","See FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250702_01"
Vk_20250702_01,2025-07-08,2026-05-08,"new systems added","Philips Medical Systems Nederland B.V.","SmartPath to dStream","MD: Full-body MRI system, superconducting magnet","See FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250702_01"
Vk_20250702_01,2025-07-08,2026-05-08,"new systems added","Philips Medical Systems Nederland B.V.","MR 7700","MD: Full-body MRI system, superconducting magnet","See FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250702_01"
Vk_20250702_01,2025-07-08,2026-05-08,"new systems added","Philips Medical Systems Nederland B.V.","Evolution Upgrade","MD: Full-body MRI system, superconducting magnet","See FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250702_01"
Vk_20250702_01,2025-07-08,2026-05-08,"new systems added","Philips Medical Systems Nederland B.V.",Intera,"MD: Full-body MRI system, superconducting magnet","See FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250702_01"
Vk_20250702_01,2025-07-08,2026-05-08,"new systems added","Philips Medical Systems Nederland B.V.",Achieva,"MD: Full-body MRI system, superconducting magnet","See FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250702_01"
Vk_20260429_006,2026-04-30,2026-05-08,"New languages","Staar Surgical AG","IOD Software","MD: Various ophtalmology instruments - software accessories",,,,8,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260429_006"
Vk_20260429_046,2026-04-30,2026-05-08,"additional languages added","Philips Medical Systems Nederland B.V. ","Zenition 30","MD: Stationary angiographic x-ray system, digital",718076,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260429_046"
Vk_20260429_046,2026-04-30,2026-05-08,"additional languages added","Philips Medical Systems Nederland B.V. ","Zenition 10","MD: Stationary angiographic x-ray system, digital",718401,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260429_046"
Vk_20260505_038,2026-05-08,2026-05-08,,"Merit Medical Systems Inc.","Merit SplashWire Hydrophilic Steerable Guide Wire","MD: Peripheral vascular guidewire, manual","MSWSTDA3580, MSWSTDA35150, MSWSTDA35180, MSWSTDA35260EX, MSWSTDS35150, MSWSTFA3580, MSWSTFS35150, MSWSTFA35260EX; ",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260505_038"
Vk_20241011_47,2024-10-23,2026-05-08,"add. devices affected","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_20260430_007,2026-05-07,2026-05-07,,"Medartis AG","5.0 headedCCS Long Thread 50/20mm, 1/Pkg","MD: Bone fixation screws, tendon and ligament synthesis screws",A-8216.50/1,"See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260430_007"
Vk_20260407_027,2026-04-09,2026-05-07,"add new language","Abbott Point of Care Inc.","i-STAT EG7+ Cartridges","IVD: Blood gas/haemoximetry analyser IVD, point-of-care",03P76-25,"N25213; N25218 ",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260407_027"
Vk_20260407_027,2026-04-09,2026-05-07,"add new language","Abbott Point of Care Inc.","i-STAT EG6+ cartridge","IVD: Blood gas/haemoximetry analyser IVD, point-of-care","; 03P77-25",N25223A,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260407_027"
Vk_20260427_029,2026-05-07,2026-05-07,,"Stryker GmbH","VariAx2 LOCKING SCREW, Full Thread, 3.5 X L28MM","MD: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile",657328,AM5253,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260427_029"
Vk_20260507_021,2026-05-07,2026-05-07,,"Medtronic, Inc.","Pocket Adaptor Kit for Deep Brain Stimulation","MD: Cerebral implantable neurostimulators - accessories","64001 and 64002; ",,all,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260507_021"
Vk_20260414_050,2026-04-16,2026-05-06,"Update of scope","Medline Industries LP","Namic Systems","MD: Fluid Management","; see FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260414_050"
Vk_20260427_058,2026-04-28,2026-05-06,"additional languages added","Philips Medical Systems Nederland B.V. ",Allura,"MD: Stationary angiographic x-ray system, digital","See FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260427_058"
Vk_20260427_058,2026-04-28,2026-05-06,"additional languages added","Philips Medical Systems Nederland B.V. ",Azurion,"MD: Stationary angiographic x-ray system, digital","See FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260427_058"
Vk_20260427_056,2026-04-28,2026-05-06,"additional languages added","Philips Medical Systems Nederland B.V. ",Azurion,"MD: Stationary angiographic x-ray system, digital","See FSN; ",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260427_056"
Vk_20260501_025,2026-05-05,2026-05-05,,"Boston Scientific Neuromodulation Corporation","TCN and CSK Reusable Radiofrequency (RF) Electrode","MD: Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable","see FSN",all,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260501_025"
Vk_20260428_033,2026-05-05,2026-05-05,,"REFLEXX S.p.A.","REFLEXX ","MD: Nitrile examination / treatment gloves",N100,2411400078,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260428_033"
Vk_20251110_06,2025-11-11,2026-05-01,"FSN update","Olympus Medical Systems Corp.","PolyLoop SINGLE USE LIGATING DEVICE","MD: Polypectomy endoscopic ligator, single-use","HX-400U-30; N5382130",All,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251110_06"
Vk_20260402_035,2026-04-08,2026-04-30,"missing information was added in the repair guidance","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-MOBILE",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260402_035"
Vk_20260423_012,2026-04-28,2026-04-30,"Extended scope of affected Devices, new FSN","Espansione Marketing SpA","EYE MASK","MD: Red-light phototherapy unit, professional","See FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260423_012"
Vk_20260427_001,2026-04-27,2026-04-29,"updated measures","ARTIQO GmbH","ELEC plus Keramik-Kugelkopf","MD: Prostheses, Joint, Hip, Femoral Component","See FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260427_001"
Vk_20260423_028,2026-04-29,2026-04-29,,"Abbott Medical",Proclaim,"MD: Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable","3363, 3660, 3661, 3662, 3663, 3664, 3665, 3667",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260423_028"
Vk_20260424_016,2026-04-29,2026-04-29,,"Maquet Cardiopulmonary GmbH","Cardiohelp II Base Unit","MD: Cardiopulmonary bypass system, roller type","701077135; 701077135",,all,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260424_016"
Vk_20260424_003,2026-04-29,2026-04-29,,VitalScientific,"GAMMA-GT PLUS SL","IVD: Gamma glutamyltransferase",GISL-0250,"All batches",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260424_003"
Vk_20260422_017,2026-04-27,2026-04-27,,"BioFire Diagnostics, LLC","BioFire® Joint Infection (JI) Panel","IVD: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)","RFIT-ASY-0138; RFIT-ASY-0138","0883425 and 0878825",N/A,N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260422_017"
Vk_20260421_026,2026-04-22,2026-04-27,"Added FR & IT","Otto Bock Mobility Solutions GmbH",Zenit,"MD: Push-rim manual wheelchair, non-bariatric","480F160=1_AA02_C, 480F160=1_AA04_C",,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260421_026"
Vk_20260421_026,2026-04-22,2026-04-27,"Added FR & IT","Otto Bock Mobility Solutions GmbH","Avantgarde 4","MD: Push-rim manual wheelchair, non-bariatric","480F160=0_AA01_C, 480F160=0_AA02_C, 480F160=0_AA03_C, 480F160=0_AC02_C",,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260421_026"
Vk_20260415_020,2026-04-27,2026-04-27,"Unterschrift geschwärzt","Shenzhen Leaflife Technology Co., Ltd","Laser Therapy Device","MD: Therapeutic lasers",LM-L808A,,"See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260415_020"
Vk_20260119_022,2026-04-24,2026-04-24,,"Goodwood Medical Care Ltd.","Large tipped applicator","MD: Swab, cotton","6'; 137434",24473G0706,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260119_022"
Vk_20260402_005,2026-04-24,2026-04-24,,"Katalyst Surgical LLC","DEX forceps and scissors","MD: Ophthalmic soft-tissue manipulation forceps, probe-like, single-use","; See FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260402_005"
Vk_20260327_006,2026-04-13,2026-04-24,"new languages","Dexcom, Inc.","Dexcom G7 iOS CGM App","MD: Percutaneous interstitial fluid glucose monitoring system, electrochemical","SW12300, SW13355",,,"versions 2.9.0 through 2.11.2","https://fsca.swissmedic.ch/mep/#?q=Vk_20260327_006"
Vk_20260421_006,2026-04-23,2026-04-23,,"Breas Medical AB","Vivo 45LS","MD: Pulmonary ventilators for non–hospital use","; 230000","See FSN",,"3.2.1 / 7.2.1","https://fsca.swissmedic.ch/mep/#?q=Vk_20260421_006"
Vk_20250704_28,2025-07-08,2026-04-22,"New instructions","Siemens Healthcare Diagnostics Inc.","Atellica CH Diazo Total Bilirubin","IVD: Total bilirubin IVD, kit, spectrophotometry",11537220/00630414614922,"All lots",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250704_28"
Vk_20240708_09,2024-07-09,2026-04-22,Produkteinstellung,"Philips Respironics, Inc","BiPAP A30 EFL","MD: Portable electric ventilator","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240708_09"
Vk_20240708_09,2024-07-09,2026-04-22,Produkteinstellung,"Philips Respironics, Inc","BiPAP A40 EFL","MD: Portable electric ventilator","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240708_09"
Vk_20240708_09,2024-07-09,2026-04-22,Produkteinstellung,"Philips Respironics, Inc","BiPAP A40 Pro","MD: Portable electric ventilator","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240708_09"
Vk_20260413_002,2026-04-21,2026-04-21,,"Micro-Mega SA","B5 ONE FLARE n25 9% L17 Classics sterile","MD: Rotary/reciprocating endodontic file/rasp, reusable","20952201; ",941846,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260413_002"
Vk_20260417_003,2026-04-21,2026-04-21,,"GE Medical Systems, LLC and GE Healthcare Japan Corporation","Revolution CT","MD: Full-body CT system",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260417_003"
Vk_20260417_003,2026-04-21,2026-04-21,,"GE Medical Systems, LLC and GE Healthcare Japan Corporation","Revolution Apex","MD: Full-body CT system",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260417_003"
Vk_20260417_003,2026-04-21,2026-04-21,,"GE Medical Systems, LLC and GE Healthcare Japan Corporation","Revolution Ascend","MD: Full-body CT system",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260417_003"
Vk_20260420_031,2026-04-21,2026-04-21,,"Neuromedex GmbH","Medistrip Vein Stripper","MD: Stripper, vein",01.3200,"304069, 305165, 306157, 306200, 305004, 305164",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260420_031"
Vk_20260408_029,2026-04-14,2026-04-21,"added new language","Medtronic, Inc.","SynchroMed Clinician Programmer Application","MD: Implantable pumps programmers - medical device software","A810; ",,All,"v1.x and 2.x","https://fsca.swissmedic.ch/mep/#?q=Vk_20260408_029"
Vk_20260415_032,2026-04-21,2026-04-21,,"The Binding Site Group Limited","EXENT analyser","IVD: Mass spectrometry analyser IVD",IE800,,A1235582,v1.0.18,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260415_032"
Vk_20260408_028,2026-04-14,2026-04-20,"Added new language","Brahms GmbH, part of Thermofisher Scientific","B·R·A·H·M·S PlGF Plus KRYPTOR","IVD: Fertility / pregnancy hormones / proteins",859075N,"59171; 59177",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260408_028"
Vk_20260415_002,2026-04-20,2026-04-20,,"Zimmer, Inc.","Disposable Mixing Bowls with Spatula","MD: Orthopaedic cement preparation and application devices and kits","see FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260415_002"
Vk_20260413_016,2026-04-14,2026-04-17,"New languages","Arrow International LLC (Subsidiary of Teleflex Incorporated)","Arrow Edge Hemodialysis Catheterization Product","MD: Double-lumen haemodialysis catheter, implantable","See FSN","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260413_016"
Vk_20260413_016,2026-04-14,2026-04-17,"New languages","Arrow International LLC (Subsidiary of Teleflex Incorporated)","NextStep Retrograde Chronic Hemodialysis Catheter","MD: Double-lumen haemodialysis catheter, implantable","See FSN","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260413_016"
Vk_20260413_016,2026-04-14,2026-04-17,"New languages","Arrow International LLC (Subsidiary of Teleflex Incorporated)","NextStep Antegrade Chronic Hemodialysis Catheter","MD: Double-lumen haemodialysis catheter, implantable","See FSN","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260413_016"
Vk_20260413_016,2026-04-14,2026-04-17,"New languages","Arrow International LLC (Subsidiary of Teleflex Incorporated)","Cannon II Plus Chronic Hemodialysis Catheter","MD: Double-lumen haemodialysis catheter, implantable","; See FSN","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260413_016"
Vk_20260413_016,2026-04-14,2026-04-17,"New languages","Arrow International LLC (Subsidiary of Teleflex Incorporated)","Arrow-Clark VectorFlow Retrograde Chronic Hemodialysis Catheter","MD: Double-lumen haemodialysis catheter, implantable","See FSN","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260413_016"
Vk_20260413_016,2026-04-14,2026-04-17,"New languages","Arrow International LLC (Subsidiary of Teleflex Incorporated)","Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter","MD: Double-lumen haemodialysis catheter, implantable","See FSN","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260413_016"
Vk_20260414_004,2026-04-16,2026-04-17,"added italian version","WINNCARE FRANCE","Demi-barrieres coulissantes","MD: Bedrail","A696-00 / A696-00Z1 / A697-00 / A697-00Z1",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260414_004"
Vk_20250919_30,2025-09-23,2026-04-17,"PV updated FSN f,i","Alcon Laboratories, Inc.","ULTRAVIT Vitrectomy Probe","MD: Vitrectomy system handpiece tip","See FSN; ",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250919_30"
Vk_20250919_30,2025-09-23,2026-04-17,"PV updated FSN f,i","Alcon Laboratories, Inc.","HYPERVIT Vitrectomy Probe","MD: Vitrectomy system handpiece tip","See FSN; ",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250919_30"
Vk_20260311_045,2026-03-17,2026-04-17,"Updated information","DH Healthcare GmbH","ORBIS Medication 3.x","MD: General medicine instruments - other",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260311_045"
Vk_20260327_009,2026-04-17,2026-04-17,,"Edwards Lifesciences LLC","Swan-Ganz Jr Catheters","MD: Vital signs monitoring instruments - consumables","SGPT54, SGPT64P, SGPT755P","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260327_009"
Vk_20260327_009,2026-04-17,2026-04-17,,"Edwards Lifesciences LLC","Swan-Ganz Pacing Catheters","MD: Invasive cardiac stimulators",D200F7,"see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260327_009"
Vk_20260327_009,2026-04-17,2026-04-17,,"Edwards Lifesciences LLC","Swan-Ganz Catheters","MD: Vital signs monitoring instruments - consumables","131F7/131F7P, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 831F75/831F75P, TS105F5, 774F75, 777F8, AIQSGF8","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260327_009"
Vk_20260326_049,2026-04-01,2026-04-16," added Languages","Getinge Sterilization AB","HS66, GEVC, GE small, GEC small, GEV small","MD: Steam sterilizer","See FSN; See FSN","See FSN","See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260326_049"
Vk_20260408_027,2026-04-09,2026-04-15,"added new language","Boston Scientific Coorpration",SMARTFREEZE,"MD: Cardiac cryosurgical system","see FSN; see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260408_027"
Vk_20260408_027,2026-04-09,2026-04-15,"added new language","Boston Scientific Coorpration",POLARxFit,"MD: Cardiac cryosurgical system catheter","see FSN; see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260408_027"
Vk_20260408_027,2026-04-09,2026-04-15,"added new language","Boston Scientific Coorpration",PolarX,"MD: Cardiac cryosurgical system catheter","see FSN; see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260408_027"
Vk_20260408_027,2026-04-09,2026-04-15,"added new language","Boston Scientific Coorpration",POLARSHEATH,"MD: Vascular guide-catheter, single-use","see FSN; see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260408_027"
Vk_20260410_043,2026-04-14,2026-04-14,,"Medline Industries LP","Namic RA syringes","MD: Angiography Syringes","; see FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260410_043"
Vk_20260408_036,2026-04-14,2026-04-14,,"Intuitive Surgical","Da Vinci X / Xi Surgical System","MD: Robotic surgical arm system","S4000, IS4200; ",,"SK0501, SK2371, SK1327, SK2207, SK6745, SK3871",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260408_036"
Vk_20211126_05,2021-12-06,2026-04-14,"adding more languages","Datascope Corp.","CARDIOSAVE Hybrid Intra-Aortic Balloon Pump","MD: Intra-aortic balloon pump","0998-00-0800-XX, 0998-UC-0800-XX",All,"All Cardiosave serial numbers distributed since March 6, 2012 to present and ongoing.",N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20211126_05"
Vk_20260413_030,2026-04-14,2026-04-14,,"CompuGroup Medical Software GmbH","CGM CLINICAL Liquid Balance","MD: Medical device software - not included in other classes",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260413_030"
Vk_20260413_030,2026-04-14,2026-04-14,,"CompuGroup Medical Software GmbH","CGM CLINICAL Assessments","MD: Medical device software - not included in other classes",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260413_030"
Vk_20260413_030,2026-04-14,2026-04-14,,"CompuGroup Medical Software GmbH","CGM CLINICAL Medication","MD: Medical device software - not included in other classes",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260413_030"
Vk_20260413_008,2026-04-14,2026-04-14,,"Immucor Inc.","Capture-R Ready-ID","IVD: Blood group antibody 2 cell screening kit","0006456, 0006457",DN162,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260413_008"
Vk_20260413_008,2026-04-14,2026-04-14,,"Immucor Inc.",Panocell-16,"IVD: Antibody identification cell panel kit",0002332,"03347, 03447ZA ",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260413_008"
Vk_20260410_042,2026-04-14,2026-04-14,,"Medline Industries LP","Namic RA syringes","MD: Angiography Syringes","see FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260410_042"
Vk_20260402_045,2026-04-08,2026-04-13,"added new language","Nucletron B.V.","Intra uterine tube with 4 mm diameter","MD: Cervical/intrauterine brachytherapy system applicator, remote-afterloading","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260402_045"
Vk_20260326_053,2026-04-10,2026-04-13,"added FR, IT, DE","Hologic Inc","Selenia Dimensions Mammography System","MD: Stationary mammographic x-ray system, digital","See FSN",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260326_053"
Vk_20260326_053,2026-04-10,2026-04-13,"added FR, IT, DE","Hologic Inc","3Dimensions Mammography System","MD: Stationary mammographic x-ray system, digital","See FSN",,"All ",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260326_053"
Vk_20251107_11,2025-11-13,2026-04-13,"Added new langugae for: mandatory SW update available","Philips Medizinsysteme Böblingen GmbH","IntelliVue Patient Monitor","MD: Multiple vital physiological parameter monitoring system, clinical","M8102A, M8105A, M8001A, M8002A, M8003A, M8004A, M8005A, M8007A, M8008A, M8010A, M3002A, 867030, 867033, 866060, 866061, 866062, 866064, 866066, 865242, 865241, 866471, 865240, 866470",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251107_11"
Vk_20260206_030,2026-02-19,2026-04-13,"Added new language","GROUPE LÉPINE","METACARPAL STEM MAIA","MD: HAND PROSTHESES TRAPEZIO-METACARPAL COMPONENTS","M100 0018; M100 0018",275277600,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260206_030"
Vk_20250523_07,2025-05-27,2026-04-09,"Additional Languages","Intersurgical Ltd","Varius BVM Resuscitators","MD: Anaesthesia face mask, single-use","see FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250523_07"
Vk_20260310_044,2026-03-23,2026-04-08,"Updated information","DH Healthcare GmbH","ORBIS Medication 3.x","MD: General medicine instruments - other",,,,03.21.01.02,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260310_044"
Vk_20260326_025,2026-03-31,2026-04-08,"added new languages","Advanced Bionics","M Zn Air Battery Pak","MD: Cochlear implant/auditory brainstem implant battery","CI-5501; ","All Lots manufactured up to February 3, 2026.",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260326_025"
Vk_20260312_035,2026-04-02,2026-04-02,,"Gyrus ACMI Inc.","Soltive Laser System","MD: General/multiple surgical solid-state laser system","TFL-PLS, TFL-SLS, TFL-CPLU, TFL-CSLU; EGTFL-PLS, EGTFL-SLS, EGTFL-CPLU, EGTFL-CSLU",,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260312_035"
Vk_20260325_048,2026-04-01,2026-04-01,,"Ivoclar Vivadent AG","Adhese 2 ","MD: Dental bonding agents","See FSN; See FSN","See FSN","See FSN",N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260325_048"
Vk_20260325_016,2026-04-01,2026-04-01,,"Immucor Inc.",Panocell-20,"IVD: Antibody identification panel reagent red blood cell IVD, kit, agglutination",,"44270 44270Z",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260325_016"
Vk_20260327_027,2026-03-31,2026-03-31,,"PHYSIO-CONTROL, Inc.","INFANT CHILD REDUCED ENERGY ELECTRODES","MD: External defibrillation electrode, paediatric, single-use","11101-000016, 11101-000017","315303, 315858, 316007, 318931, 320529, 315639",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260327_027"
Vk_20260331_012,2026-03-31,2026-03-31,,"Lumenis Ltd","CO2 Laser Systems and VersaPulse PowerSuite (VPPS)","MD: General/multiple surgical solid-state laser system","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260331_012"
Vk_20260326_026,2026-03-31,2026-03-31,,"Heraeus Medical GmbH","PALAMIX DUO","MD: Manual orthopaedic cement mixer, reusable",66057897,"all batches with numbers below 520215",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260326_026"
Vk_20260326_026,2026-03-31,2026-03-31,,"Heraeus Medical GmbH","PALAMIX UNO","MD: Manual orthopaedic cement mixer, reusable","; 66057893","all batches with numbers below 223060",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260326_026"
Vk_20260327_025,2026-03-31,2026-03-31,,"Edwards Lifesciences LLC","EVOUQE Tricuspid Delivery System","MD: Cardiac valve transcatheter implant accessories","9850TDS; 9850TDS",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260327_025"
Vk_20260326_027,2026-03-31,2026-03-31,,"INFINITT Healthcare Co., Ltd.","INFINITT PACS 7.0","MD: Radiological PACS software",,,,"INFINITT PACS 7.0.0.8 BN01021","https://fsca.swissmedic.ch/mep/#?q=Vk_20260326_027"
Vk_20260318_029,2026-03-30,2026-03-30,,"Medtronic, Inc., BIOTRONIK SE & Co. KG","Sphere-9 Catheter","MD: Cardiac tissue ablation devices - other","AFR-00001; ",All,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260318_029"
Vk_20260317_001,2026-03-30,2026-03-30,"additional languages added","NEXUS / CMC GmbH","NEXUS / MEDIKATION","MD: General medicine therapeutic treatment instruments - medical device software",,,,"24.2, 25.3 and 25.4","https://fsca.swissmedic.ch/mep/#?q=Vk_20260317_001"
Vk_20260319_028,2026-03-24,2026-03-30,"Missing FSN in Italian (Version 1_1) published","Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation","ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 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","Brady SMR5 Model 3869 v2.04","https://fsca.swissmedic.ch/mep/#?q=Vk_20260319_028"
Vk_20260310_007,2026-03-11,2026-03-30,"added new language","Gyrus ACMI Inc.","PK Cutting Forceps, 5MM, 33CM","MD: Endoscopic electrosurgical handpiece/electrode, bipolar, single-use","PK-CF0533; EGPK-CF0533, K10027741",all,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260310_007"
Vk_20260310_007,2026-03-11,2026-03-30,"added new language","Gyrus ACMI Inc.","HALO PKS Cutting Forceps, 5mm x 33cm","MD: Endoscopic electrosurgical handpiece/electrode, bipolar, single-use","HACF0533; EGHACF0533, K10022068 ",all,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260310_007"
Vk_20260310_007,2026-03-11,2026-03-30,"added new language","Gyrus ACMI Inc.","Everest Cutting Forceps","MD: Endoscopic electrosurgical handpiece/electrode, bipolar, single-use","3005, 3006, 3025; EG3005, EG3006-020, K10015952, EG3025-020",all,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260310_007"
Vk_20260310_007,2026-03-11,2026-03-30,"added new language","Gyrus ACMI Inc.","PKS Cutting Forceps ","MD: Endoscopic electrosurgical handpiece/electrode, bipolar, single-use","920005PK, 3005PK, 920000PK, 3025PK; EG920005PK, EG3005PK, EG920000PK, K10010033, EG3025PK3",all,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260310_007"
Vk_20260312_040,2026-03-17,2026-03-30,"New information on identification of erroneuos results by manufacturer","Biomedical Data Solutions Limited","Ortho Connect","IVD: Various General Purpose Ivd Instruments - Software Accessories ","6904413, 6904414, 6904415, 6913355, 6904410, 6904411, 6904412, 6993333, 6993332",,,V3,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260312_040"
Vk_20260326_024,2026-03-26,2026-03-26,,"Intuitive Surgical","8 mm SureForm 30 Reload, 30 mm Gray","MD: Surgical staple loading unit, non-cutting","48230M-05 and 48230M-06",all,all,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260326_024"
Vk_20260323_005,2026-03-26,2026-03-26,,"Beckman Coulter , Inc.","Access Total T4 Calibrator","IVD: Thyroxine",33805,"538729; 538815; 538898; 539107; 539243",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260323_005"
Vk_20260317_006,2026-03-17,2026-03-26,"added new languages","Vascutek Ltd","Thoraflex Hybrid","MD: Descending thoracic aorta endovascular stent-graft","Thoraflex Hybrid Ante-Flo, Thoraflex Hybrid Plexus; All Thoraflex Hybrid catalogue numbers",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260317_006"
Vk_20260320_010,2026-03-24,2026-03-26,"additional languages added","Philips Medical Systems Nederland B.V. ",AneurysmFlow,"MD: Digital angiography systems - software accessories","001015; ",,,R1.x,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260320_010"
Vk_20260317_024,2026-03-18,2026-03-25,"added new language","Biosense Webster, Inc.","TRUPULSE Generator","MD: Various instruments for cardiology and cardiac surgery",D-1417-01-12,,all,2.7.0,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260317_024"
Vk_20260317_024,2026-03-18,2026-03-25,"added new language","Biosense Webster, Inc.","Dual Energy THERMOCOOL SMARTTOUCH SF Bi-Directional Catheter","MD: Arrhythmogenic Foci Ablation Leads Via Other Energy Sources","D134711; D134712; D134814; D134815",All,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260317_024"
Vk_20260310_029,2026-03-25,2026-03-25,,"Laboratoires Anios ","ANIOS CLEAN EXCEL D","MD: Medical device disinfection agent",,H17811S,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260310_029"
Vk_20260320_011,2026-03-25,2026-03-25,,"Siemens Healthcare Diagnostics Inc.","Atellica CH Creatine Kinase (CK_L)","IVD: Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry","N/A; 11097640","252591, 252602 and 252612",N/A,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260320_011"
Vk_20260318_043,2026-03-24,2026-03-24,,"GE Medical Systems LLC","SIGNA Premier","MD: Magnetic resonance (mr) systems","00840682135269, 00195278010797",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260318_043"
Vk_20260323_054,2026-03-24,2026-03-24,,"DH Healthcare GmbH","ORBIS Medication 3.x","MD: General medicine instruments - other",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260323_054"
Vk_20260312_026,2026-03-17,2026-03-24,"added new languages","Masimo Corporation","Radius VSM ECG Electrodes & Blood pressure Cuffs","MD: Indwelling urethral drainage balloon catheter, non-antimicrobial","4695, 4842, 4825, 4826; 4695, 4842, 4825, 4826","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260312_026"
Vk_20260318_046,2026-03-24,2026-03-24,,"Gyrus ACMI Inc.","THUNDERBEAT II Shears with Ultrasonic Mode","MD: Endoscopic electrosurgical/ultrasonic surgical sys","TB2-0520FC, TB2-0525FC, TB2-0535FC, TB2-0545FC.; R5001008, R5001009, R5001010, R5001011.",All,n.a,n.a,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260318_046"
Vk_20260305_008,2026-03-23,2026-03-23,,"Resoundant, Inc.","Resoundant Acoustic Driver System","MD: Various magnetic resonance imaging instruments – other",RESYS4001-RESYSAB,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260305_008"
Vk_20260318_001,2026-03-23,2026-03-23,,"Siemens Healthcare Diagnostics Inc.","Enzymatic Hemoglobin A1c (A1c_E) reagents","IVD: Glycated haemoglobin (HbA1c) IVD, kit, spectrophotometry","N/A; 11097536","All lots",N/A,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260318_001"
Vk_20260310_038,2026-03-18,2026-03-23,"FSN d,f","In Log S.A.S",EdgeSuite,"MD: Medical Device Software - Not Included In Other Classes",,,,"7.2.0 and previous versions","https://fsca.swissmedic.ch/mep/#?q=Vk_20260310_038"
Vk_20260312_038,2026-03-18,2026-03-20,"Affected devices corrected","Greiner Bio One","VACUETTE Multiple Use Drawing Needle 22G","MD: Needles for collection under vacuum, w/o safety systems",450075,"25J01B, 25J03C, 25J07B, 25J09B, 25J09C, 25J29B, 25K06B, 25K11B, 25K12B, 25J08B, 25J07C",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260312_038"
Vk_20260310_015,2026-03-19,2026-03-19,,"Siemens Healthcare Diagnostics Inc.","ADVIA Centaur Actives-B12 (Holotranscobalamin) (AB12)","IVD: Holotranscobalamin (holoTC) IVD, kit, chemiluminescent immunoassay","10995088, 00630414603100; 10995088",65223112,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260310_015"
Vk_20260310_015,2026-03-19,2026-03-19,,"Siemens Healthcare Diagnostics Inc.","Atellica IM Active-B12 (Holotranscobalamin) (AB12)","IVD: Holotranscobalamin (holoTC) IVD, kit, chemiluminescent immunoassay","10733001, 00630414245720; 10733001","62381103, 62382104, 62765105, 62759108, 65207111",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260310_015"
Vk_20260305_010,2026-03-11,2026-03-19,"added new languages","Cook Incorporated","Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set","MD: Tracheostomy kit, single-use","G57685, G57687; C-PTIS-100-HC-G-EU, C-PTIS-100-UNL-HC-G-EU","16189446, 16175953, 16175957; 16471138, 16131781",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260305_010"
Vk_20260316_031,2026-03-18,2026-03-18,,"KLS Martin SE & Co. KG","marClamp Cut IQ w.instrum.coding","MD: Open-surgery electrosurgical handpiece/electrode, bipolar, reusable",80-632-23-04,"see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260316_031"
Vk_20260305_023,2026-03-11,2026-03-18,"additional languages added","Philips Medical Systems Nederland B.V. ","Vue PACS","MD: Radiological PACS software",1017979,,,"v12.2.0 - v12.2.8.500","https://fsca.swissmedic.ch/mep/#?q=Vk_20260305_023"
Vk_20260312_022,2026-03-17,2026-03-17,,"Elekta Solutions AB","Leksell Vantage Arc System","MD: Neurological stereotactic surgery system",1053958,,00001–00625,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260312_022"
Vk_20260313_027,2026-03-17,2026-03-17,,Lutronic,"CLARITY II","MD: Dermatological solid-state laser system","all; all",all,all,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260313_027"
Vk_20260305_040,2026-03-17,2026-03-17,,"Derma Sciences Inc.","MediHoney Antibacterial Wound Gel","MD: Medical honey liquid barrier dressing",COM389/COM60060,"All unexpired lots",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260305_040"
Vk_20260312_021,2026-03-17,2026-03-17,,"Olympus Winter & Ibe GmbH","HF cable bipolar","MD: Cables/Leads, Electrosurgical Unit","WA00014A; WA00014A",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260312_021"
Vk_20260223_057,2026-03-01,2026-03-16,"Added new language","Diagnostica Stago","sthemO 301","IVD: Coagulation analyser IVD, laboratory",59018,,"All serial numbers",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260223_057"
Vk_20260223_057,2026-03-01,2026-03-16,"Added new language","Diagnostica Stago","sthemO 201","IVD: Coagulation analyser IVD, laboratory",59032,,"All serial numbers",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260223_057"
Vk_20260312_018,2026-03-16,2026-03-16,,"B. Braun Melsungen AG","B. Braun Space Plus Perfusor","MD: Bedside syringe pump",8719030,,,"019D0005 (D05)","https://fsca.swissmedic.ch/mep/#?q=Vk_20260312_018"
Vk_20260305_025,2026-03-10,2026-03-13,"new languages added","Philips Medical Systems Nederland B.V. ","Allura Centron","MD: Stationary general-purpose fluoroscopic x-ray system, analogue","See FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260305_025"
Vk_20260305_025,2026-03-10,2026-03-13,"new languages added","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_20260305_025"
Vk_20260305_025,2026-03-10,2026-03-13,"new languages added","Philips Medical Systems Nederland B.V. ",Azurion,"MD: Stationary angiographic x-ray system, digital","See FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260305_025"
Vk_20260305_025,2026-03-10,2026-03-13,"new languages added","Philips Medical Systems Nederland B.V. ","Allura CV20","MD: Stationary angiographic x-ray system, digital","See FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260305_025"
Vk_20241223_27,2025-01-08,2026-03-13,"Correction to FSN additional language EN","Intuitive Surgical, Inc","EndoWrist Tenaculum Forceps","MD: Robotic surgical forceps, reusable",470207,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241223_27"
Vk_20241223_27,2025-01-08,2026-03-13,"Correction to FSN additional language EN","Intuitive Surgical, Inc","EndoWrist Small Grasping Retractor","MD: Robotic surgical retractor",470318,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241223_27"
Vk_20260305_041,2026-03-12,2026-03-12,,"AngioDynamics, Inc.","Angiographic Catheters","MD: Angiography And Haemodynamic Devices","Soft-Vu and Accu-Vu 4 FR Angiographic Catheters; H787107140015, H787107140025, H787107140145, H787107314015, H787107323015","A3525030, A2525060, A2825133, A2825042, A3025037",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260305_041"
Vk_20260226_023,2026-03-04,2026-03-12,"added new languages","Instrumentation Laboratory Company","GEM Premier 5000 PAK","IVD: Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies",,"See FSN","See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260226_023"
Vk_20260306_003,2026-03-12,2026-03-12,,"Pathonostics B.V.","DermaGenius 3.0 Complete Multiplex real-time PCR","IVD: Pneumocystis jirovecii nucleic acid IVD, kit, nucleic acid technique (NAT)",PN-402,"LPN2024081 - only if shipped between 30-01-2025 and 17-02-2025",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260306_003"
Vk_20260305_009,2026-03-10,2026-03-10,,"Intuitive Surgical","EndoWrist Mega Needle Driver","MD: Robotic surgical needle holder, reusable","420194-13, 420194-12, 420194-11, 420194-10, 420194-08, 420194-05, 420194-03; 420194",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260305_009"
Vk_20260305_009,2026-03-10,2026-03-10,,"Intuitive Surgical","da Vinci EndoWrist Monopolar Curved Scissors","MD: Robotic electrosurgical instrument, monopolar, reusable","420179-23, 420179-22, 420179-21, 420179-20, 420179-19, 420179-18, 420179-16, 420179-15, 420179-14, 420179-12, 420179-10; 420179",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260305_009"
Vk_20260305_009,2026-03-10,2026-03-10,,"Intuitive Surgical","Grasping Retractor","MD: Robotic surgical forceps, reusable","420278-09, 420278-08, 420278-07, 420278-06, 420278-04; 420278",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260305_009"
Vk_20260305_009,2026-03-10,2026-03-10,,"Intuitive Surgical","Double Fenestrated Grasper","MD: Robotic surgical forceps, reusable","420189-12, 420189-11, 420189-10, 420189-09, 420189-107; 420189",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260305_009"
Vk_20260305_007,2026-03-10,2026-03-10,,"Intuitive Surgical","EndoWrist Permanent Cautery Hook","MD: Robotic electrosurgical instrument, monopolar, reusable","420183-16, 420183-15, 420183-14, 420183-12, 420183-11, 420183-10, 420183-06, 420183-05; 420183",All,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260305_007"
Vk_20260305_007,2026-03-10,2026-03-10,,"Intuitive Surgical","EndoWrist Tenaculum Forceps","MD: Robotic surgical forceps, reusable","420207-10, 420207-09, 420207-07, 420207-06, 420207-04; 420207",All,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260305_007"
Vk_20260120_07,2026-01-27,2026-03-09,"add new languages (FR; IT)","Ossenberg GmbH","KLASSIKER, KIDDY, JUNIOR, EASY, LM-Stock KIDDY","MD: Walkers, standard","LM-Stock KIDDY",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260120_07"
Vk_20260302_022,2026-03-05,2026-03-05,,"Integra LifeSciences (Ireland) Limited","CUSA Clarity Console","MD: Soft-tissue ultrasonic surgical system",C7000,,"see FSN","software 2.1.1.909","https://fsca.swissmedic.ch/mep/#?q=Vk_20260302_022"
Vk_20260227_034,2026-03-05,2026-03-05,,"Naturdrogerie Frey AG","PANDEMIE Analoger Thermometer Fiebermesser","MD: clinical thermometer",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260227_034"
Vk_20260302_002,2026-03-05,2026-03-05,,"K2M, Inc.","Everest MI 1 Level Kit, Retractors/Wires; Size Ø1.4 mm (Qty 4 ea) SS","MD: Orthopaedic surgical procedure kit, non-medicated, single-use",5101-90077,WRCW-002,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260302_002"
Vk_20260302_025,2026-03-04,2026-03-04,"Device name corrected with trade name","Merit Medical Systems Inc.","16F Dual-Valved Splittable Sheath Introducer","MD: Double-lumen haemodialysis catheter, implantable","see FSN; see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260302_025"
Vk_20260223_011,2026-03-04,2026-03-04,,"Wilson-Cook Medical Inc","INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE","MD: Gastrointestinal endoscopic clip, long-term, non-bioabsorbable",INSC-P-7-230-S,"All INSC-P devices manufactured from 09-Feb-2023 to 20-Apr-2025.",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260223_011"
Vk_20260226_013,2026-03-03,2026-03-03,"FSN doppelt publiziert. ",Mentor,"CPX 4 with Suture Tabs Tissue Expander","MD: Skin-port tissue expander",3549123,2164677,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260226_013"
Vk_20260226_013,2026-03-03,2026-03-03,"FSN doppelt publiziert. ",Mentor,"CPX 4 Tissue Expander","MD: Skin-port tissue expander",3548222,"2160707, 2157852",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260226_013"
Vk_20260302_018,2026-03-03,2026-03-03,"""See FSN"" instead of ""Please see Field Safety Notice""","GE Healthcare","Centricity Universal Viewer","MD: Medical image management system",,,,"See FSN","https://fsca.swissmedic.ch/mep/#?q=Vk_20260302_018"
Vk_20260130_20,2026-02-05,2026-03-01,"Added new language","DIAGNOSTICA STAGO","STA LIATEST DDI PLUS","IVD: D-dimer IVD, kit, agglutination",00662,"272627; 272742; 273170; 273171; 273230; 273468; 273518; 273711",/,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260130_20"
Vk_20260202_015,2026-02-09,2026-02-26,"FSN d,f published, FSN e has small changes (now: all SN are affected, before: affected SN see FSN)","Abiomed Inc.","Impella RP","MD: Intracardiac circulatory assist axial-pump catheter","0046-3107; 0046-0011",All,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260202_015"
Vk_20260220_036,2026-02-24,2026-02-24,,"OLYMPUS MEDICAL SYSTEMS CORP.","Single Use Biopsy Valve","MD: Endoscope working-channel valve, single-use","MAJ 210; NGL2167, N6210355, 028988","All unexpired & unused- all lots within shelf life of 36 months",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260220_036"
Vk_20260219_045,2026-02-24,2026-02-24,,"Convatec Ltd","Esteem Body","MD: One-piece intestinal ostomy bag, open-ended","423642, 423643, 423644, 423651, 423657","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260219_045"
Vk_20260218_030,2026-02-24,2026-02-24,,"implantcast GmbH","HAPTic PIP-System","MD: Orthopaedic Surgery Rasps, Reusable","00515021, 09300255xx, HAPTSTxx",,"The FSCA only concerns the instructions for use and the surgical technique of the HAPTic® PIP-System.",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260218_030"
Vk_20260220_020,2026-02-24,2026-02-24,,"IMACTIS SAS","IMACTIS® CT-Navigation™ System","MD: Robotic surgical navigation system",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260220_020"
Vk_20260216_009,2026-02-17,2026-02-23,"Additional languages","Erbe Elektromedizin GmbH","Flexible cryoprobe, single-use","MD: Endoscopic cryosurgical probe, single-use","20402-401, 20402-402, 20402-410, 20402-411",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260216_009"
Vk_20220331_20,2022-04-05,2026-02-23,"Added new language; Correction of information for recall: The correct PIN Number to be returned is 977006101K","Medtronic Inc.","Vanta with AdaptiveStim Technology Primary cell neurostimulator","MD: Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable","977006; GTIN 00763000478087",n/a,"All unused serial numbers of GTIN 00763000478087",n/a,"https://fsca.swissmedic.ch/mep/#?q=Vk_20220331_20"
Vk_20260115_32,2026-02-02,2026-02-20,"added content action taken by Roche","Hitachi High-Tech Corporation","cobas pure sample supply unit","IVD: Integrated / Modular Chemistry / Immunochemistry Instruments - Other","see FSN",,"see FSN","see FSN","https://fsca.swissmedic.ch/mep/#?q=Vk_20260115_32"
Vk_20260115_32,2026-02-02,2026-02-20,"added content action taken by Roche","Hitachi High-Tech Corporation","cobas pro sample supply unit","IVD: Multiple clinical chemistry analyser IVD, laboratory","see FSN",,"see FSN","see FSN","https://fsca.swissmedic.ch/mep/#?q=Vk_20260115_32"
Vk_20260115_32,2026-02-02,2026-02-20,"added content action taken by Roche","Hitachi High-Tech Corporation","cobas pro SSU","IVD: Integrated / Modular Chemistry / Immunochemistry Instruments - Other","see FSN",,"see FSN","see FSN","https://fsca.swissmedic.ch/mep/#?q=Vk_20260115_32"
Vk_20250227_27,2025-03-04,2026-02-20,"Updated FSN","Medtronic Inc.","MyPTM App","MD: Implantable Pumps Programmers - Medical Device Software",A820,,All,"1.x & 2.X","https://fsca.swissmedic.ch/mep/#?q=Vk_20250227_27"
Vk_20251013_19,2025-10-14,2026-02-20,"Updated information","CompuGroup Medical Software GmbH","CGM CLINICAL Medication","MD: Medical Device Software - Not Included In Other Classes",,,,"8.x, 9.x, 10.x, 11.x, 12.x","https://fsca.swissmedic.ch/mep/#?q=Vk_20251013_19"
Vk_20260218_016,2026-02-18,2026-02-18,,"Waldemar Link GmbH & Co. KG","Prosthesis Head B, Ø 28 mm","MD: Metallic femoral head prosthesis","198-828/04; 198-828/04",,"see FSN",N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260218_016"
Vk_20260213_034,2026-02-17,2026-02-17,,"DH Healthcare GmbH","DeepUnity PACSonWEB","MD: Picture Archiving And Communication Systems",,,,3.4.203,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260213_034"
Vk_20260212_039,2026-02-17,2026-02-17,,"SIGNUS Medizintechnik GmbH","DIPLOMAT Schraubendreher, Verschlussschraube","MD: Orthopaedic surgical procedure kit, non-medicated, reusable","AC0017-H; AC0018-H; AC0057-H","AC0017-H: 976466; 976468; AC0018-H: 976469; 976470; 984370; AC0057-H: 976464; 976465; 984389",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260212_039"
Vk_20260123_13,2026-02-02,2026-02-16,"Added new language","DIAGNOSTICA STAGO","STA - Liatest Free Protein S 6 and 2","IVD: Protein S IVD, kit, nephelometry/turbidimetry","00516, 00527","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260123_13"
Vk_20260210_022,2026-02-16,2026-02-16,,"BD Switzerland Sàrl","Alaris Plus Syringe Pump","MD: Bedside syringe pump","See FSN",,"See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260210_022"
Vk_20260210_022,2026-02-16,2026-02-16,,"BD Switzerland Sàrl","Alaris neXus Syringe Pump","MD: Bedside syringe pump","See FSN",,"See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260210_022"
Vk_20260213_011,2026-02-16,2026-02-16,,"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_20260213_011"
Vk_20260213_011,2026-02-16,2026-02-16,,"Medtronic MINIMED","MiniMed 670G Insulin Pump","MD: Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm","MMT-1761, MMT-1762, MMT-1781, MMT-1782",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260213_011"
Vk_20260213_011,2026-02-16,2026-02-16,,"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_20260213_011"
Vk_20260213_011,2026-02-16,2026-02-16,,"Medtronic MINIMED","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_20260213_011"
Vk_20260213_011,2026-02-16,2026-02-16,,"Medtronic MINIMED","Paradigm Insulin Infusion Pump","MD: Ambulatory insulin infusion pump, electronic","MMT-554, MMT-715, MMT-722, MMT-754",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260213_011"
Vk_20260213_011,2026-02-16,2026-02-16,,"Medtronic MINIMED","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_20260213_011"
Vk_20260213_011,2026-02-16,2026-02-16,,"Medtronic MINIMED","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_20260213_011"
Vk_20260212_003,2026-02-13,2026-02-13,,"Siemens Healthcare Diagnostics","IMMULITE 2000 EPO, IMMULITE EPO Control Module","IVD: Chemiluminescent immunoassay and Erythropoietin (EPO) IVD","N/A; L2KEPN2, L2KEPN6, LEPCM","Kit lots: 338, 339, 340, 341 QC lots: 0035, 035L",N/A,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260212_003"
Vk_20260210_023,2026-02-12,2026-02-12,,"ICU Medical Inc","CADD™ High Volume Administration Sets","MD: Electric infusion pump administration set, single-use","21-7361-24; 21-7361-24",6037805,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260210_023"
Vk_20260211_032,2026-02-12,2026-02-12,,"Covidien llc","HUGO RAS Bipolar Fenestrated Grasper","MD: Robotic Surgery Instruments, Reusable - Other",MRASI0004,,"See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260211_032"
Vk_20260211_032,2026-02-12,2026-02-12,,"Covidien llc","HUGO RAS Bipolar Maryland Forceps","MD: Robotic Surgery Instruments, Reusable - Other",MRASI0005,,"See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260211_032"
Vk_20260126_11,2026-02-04,2026-02-12,"Added new language","Zhermack SpA (former legal manufacturer: Dentsply DeTrey GmbH)","AQUASIL PUTTY SOFT and AQUASIL PUTTY HARD","MD: Dental Impression Vinylsiloxans","60578320, 60578321, 60578332, 60578333","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260126_11"
Vk_20260129_31,2026-02-03,2026-02-12,"Correction of italian version","Philips Electronics Nederland B.V.","Philips Azurion system","MD: Stationary angiographic x-ray system, digital","722063, 722064, 722078, 722079, 722067, 722068, 722229, 722230, 722231, 722232, 722233, 722234, 722280, 722221, 722222, 722227, 722228, 722223, 722224, 722225, 722226, 722281, 722282, 722235, 722236.",,,"Azurion (R1.X, R2.X, R3.X, R4.0)","https://fsca.swissmedic.ch/mep/#?q=Vk_20260129_31"
Vk_20251222_01,2026-01-16,2026-02-11,"Added new language for v2 published (FR, IT, DE)","Armstrong Medical Limited","BiPAP Tubing","MD: Ventilator breathing circuit, single-use","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251222_01"
Vk_20260128_028,2026-02-10,2026-02-10,,"Philips Medical Systems DMC GmbH","MobileDiagnost wDR","MD: Radiographic/fluoroscopic unit, mobile","712001, 712002, 712005, 712006; ",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260128_028"
Vk_20260121_10,2026-01-29,2026-02-10,"PV FSN d with acknowledgement form and FSN f,i (without acknowledgement form)",Linet,"Essenza 300","MD: Basic electric hospital bed","1EZ3; ",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260121_10"
Vk_20260204_039,2026-02-09,2026-02-09,,"GE Healthcare, GE Healthcare","Centricity Universal Viewer Zero Footprint Client","MD: Medical image management system",,,,"v6.0 SP11.6 through v6.0 SP11.6.1","https://fsca.swissmedic.ch/mep/#?q=Vk_20260204_039"
Vk_20250815_13,2025-08-19,2026-02-05,"Additional info","Siemens Healthcare GmbH","MRI system, full body","MD: Full-body MRI system, superconducting magnet","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250815_13"
Vk_20251111_27,2026-02-05,2026-02-05,,"CompuGroup Medical Software GmbH","CGM CLINICAL Medication","MD: Medical Device Software - Not Included In Other Classes",,,,"12.x, 11.1; 9.x, 10.x, 8.x (","https://fsca.swissmedic.ch/mep/#?q=Vk_20251111_27"
Vk_20250820_11,2026-02-05,2026-02-05,,"Beckman Coulter , Inc.","FRU LED HGB PHOTOMETER (Field Replacement Unit)","IVD: Haematological cell analyser IVD",D03377,,"See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250820_11"
Vk_20250820_11,2026-02-05,2026-02-05,,"Beckman Coulter , Inc.","UniCel DxH 600 Coulter Cellular Analysis System","IVD: Haematological cell analyser IVD",B23858,,"See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250820_11"
Vk_20250820_11,2026-02-05,2026-02-05,,"Beckman Coulter , Inc.","UniCel DxH 800 Coulter Cellular Analysis System","IVD: Haematological cell analyser IVD","B24802, 629029, B63322",,"See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250820_11"
Vk_20250820_11,2026-02-05,2026-02-05,,"Beckman Coulter , Inc.","UniCel DxH 900 Coulter Cellular Analysis System","IVD: Haematological cell analyser IVD",C11478,,"See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250820_11"
Vk_20250820_11,2026-02-05,2026-02-05,,"Beckman Coulter , Inc.","UniCel DxH 690T COULTER Cellular Analysis System","IVD: Haematological cell analyser IVD",C34520,,"See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250820_11"
Vk_20260127_21,2026-02-05,2026-02-05,,"Edan Instruments, Inc.","Patient Monitor","MD: Vital Signs Monitoring Instruments","X8, X10, iV100, CX10, iX10",,,"see FSN","https://fsca.swissmedic.ch/mep/#?q=Vk_20260127_21"
Vk_20260127_21,2026-02-05,2026-02-05,,"Edan Instruments, Inc.","Vital Signs Monitor","MD: Vital Signs Monitoring Instruments","M3, iM8, iM70, iM60, iM50, iM3s, iM3, iM20",,,"see FSN","https://fsca.swissmedic.ch/mep/#?q=Vk_20260127_21"
Vk_20260127_21,2026-02-05,2026-02-05,,"Edan Instruments, Inc.","Maternal and Fetal Monitor","MD: Vital Signs Monitoring Instruments","F9 Express, F9, F6 Express, F6, F3, F2",,,"see FSN","https://fsca.swissmedic.ch/mep/#?q=Vk_20260127_21"
Vk_20241223_26,2025-01-09,2026-02-05,"New Field Safety Notice","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_20260204_32,2026-02-05,2026-02-05,,"Beckman Coulter , Inc.","DxC 700 AU Chemistry Analyzer","IVD: Multiple clinical chemistry analyser IVD, laboratory","see FSN",,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260204_32"
Vk_20260204_32,2026-02-05,2026-02-05,,"Beckman Coulter , Inc.","AU5800 Clinical Chemistry Analyzer","IVD: Multiple clinical chemistry analyser IVD, laboratory","see FSN",,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260204_32"
Vk_20250805_21,2025-08-13,2026-02-04,,"Tandem Diabetes Care, Inc.","t:slim X2 Insulin Pump","MD: Ambulatory insulin infusion pump, electronic",,,,"All Versions","https://fsca.swissmedic.ch/mep/#?q=Vk_20250805_21"
Vk_20251013_03,2025-10-23,2026-02-04," how to check for tampering","Abiomed Inc.","Automated Impella Controller (AIC)","MD: Intracardiac circulatory assist axial-pump catheter control unit","0042-0040; 0042-0010; 0042-0000","This FSCA is applicable to all AIC",,"All AIC Software version are impacted.","https://fsca.swissmedic.ch/mep/#?q=Vk_20251013_03"
Vk_20260127_01,2026-02-04,2026-02-04,,"Siemens Healthcare Diagnostics Manufacturing Limited","Atellica CH Urine Albumin (UAlb)","IVD: Albumin IVD, kit, nephelometry/turbidimetry",11537225,"See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260127_01"
Vk_20230327_30,2023-03-27,2026-02-04,"Added new languages","Datascope Corp.","CARDIOSAVE® Hybrid Intra-Aortic Balloon Pump","MD: Intra-aortic balloon pump","0998-00-0800-XX, 0998-UC-0800-XX",N/A,"All Cardiosave serial numbers distributed March 6, 2012 to present",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20230327_30"
Vk_20260122_02,2026-01-28,2026-02-04,"Added new language","Olympus Medical Systems Corp.","CleverCut and FlowCut Sphincterotomes","MD: Endoscopic electrosurgical handpiece/electrode, monopolar, single-use","See FSN","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260122_02"
Vk_20260127_17,2026-02-03,2026-02-03,"Test für Medango Migration",Cepheid,"Xpert Carba-R","IVD: Nucleic Acid Identification - Manual / Automated Carbapenemase","GXCARBARP-CE-10, GXCARBAR-CE-10","13804/ 1001496782, 13902/ 1001499584, 14007/ 1001508863, 13703/ 1001497813",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260127_17"
Vk_20260129_23,2026-02-03,2026-02-03,,"Laboratoires Euromedis","Sterile surgical drapes and gowns","MD: Sterile surgical drapes and gowns","see annex","see annex",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260129_23"
Vk_20260122_34,2026-02-03,2026-02-03,,"GE Medical Systems, LLC","Omni Legend PET/CT","MD: Integrated Ct/pet Systems",,,,"SP5, SP6, SP7, SP8","https://fsca.swissmedic.ch/mep/#?q=Vk_20260122_34"
Vk_20260121_07,2026-02-02,2026-02-02,,"Olympus Winter & Ibe GmbH","Outer sheath, 22.5 Fr.","MD: Cystoscopes, Rigid",WA22810A,"see FSN","see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260121_07"
Vk_20251223_37,2025-12-23,2026-01-30,"Added new language","Roche Diagnostics GmbH","cobas HbA1c Test","IVD: Assay, glycosylated hemoglobin",09200509190,52130101,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251223_37"
Vk_20260126_12,2026-01-29,2026-01-29,,"Datascope Corp.","CS100 Intra-Aortic Balloon Pump","MD: Intra-aortic balloon pump",0998-XX-3013-XX,All,"All active CS100 serial numbers distributed 2005 - 2025",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260126_12"
Vk_20260126_12,2026-01-29,2026-01-29,,"Datascope Corp.","CS300 Intra-Aortic Balloon Pump","MD: Intra-aortic balloon pump",0998-XX-3023-XX,All,"All active CS300 serial numbers distributed 2005 - 2025",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260126_12"
Vk_20260112_25,2026-01-13,2026-01-29,"Added new language","Waldemar Link GmbH & Co. KG","Connection component; Knee Joint component","MD: Rotating hinged total knee prosthesis","Endo-Model SL; Endo-Model Knee System; customLINK","See FSN","See FSN",N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260112_25"
Vk_20251027_25,2026-01-28,2026-01-28,,"Olympus Medical Systems Corp.","EVIS EXERA III COLONOVIDEOSCOPE","MD: Flexible video colonoscope, reusable","PCF-HQ190I, PCF-H190TL, PCF-HQ190L, PCF-HQ190I, PCF-H190TI, PCF-HQ190L; N6015150, N5782940, N6015050, N6015150, N6015151, N5783040, N5783051, N6015051",,"See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251027_25"
Vk_20260126_37,2026-01-28,2026-01-28,,"Olympus Medical Systems Corp.","HIGH FLOW INSUFFLATION UNIT","MD: Laparoscopic insufflator","UHI, UHI-2, UHI-3; A5661, A90100A, A90120A (N1000161), A90120AR, N1000142",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260126_37"
Vk_20260122_37,2026-01-28,2026-01-28,,"Intuitive Surgical, Inc","Vision Probe Bag","MD: Instrument management bag","490127-01, 490127-02","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260122_37"
Vk_20241121_14,2024-11-27,2026-01-28,"Added new language","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_20250915_06,2025-09-16,2026-01-28,,"GE Medical Systems Israel Functional Imaging","Nuclear Medicine Systems","MD: Stationary gamma camera system","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250915_06"
Vk_20260122_01,2026-01-27,2026-01-27,,"BD Switzerland Sàrl","Alaris VP Infusion Sets","MD: Electric infusion pump administration set, single-use","Refer to FSN","Refer to FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260122_01"
Vk_20251219_37,2026-01-08,2026-01-23,"added new language","Hologic Inc.","Brevera Breast Biopsy System Disposable 9 Gauge N","MD: Mammographic stereotactic biopsy system",BREVDISP09,All,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251219_37"
Vk_20260114_15,2026-01-23,2026-01-23,,"DH Healthcare GmbH","ORBIS Medication 3.x","MD: General Medicine Instruments - Other",,,,03.19.00.00,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260114_15"
Vk_20260114_12,2026-01-21,2026-01-22,"Added new language","bioMérieux Inc.","VITEK 2 AST Test Kit","IVD: General-microorganism antimicrobial susceptibility culture medium IVD","see FSN","All Unexpired Lots",N/A,N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260114_12"
Vk_20260112_02,2026-01-22,2026-01-22,,"Derma Sciences","Medihoney Barrier and Derma cream","MD: Dry skin moisture barrier dressing","582; 597; 800","All unexpired lots",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260112_02"
Vk_20251218_03,2025-12-19,2026-01-22,"Added new language","Philips Medical Systems Nederland B.V.","Allura Xper","MD: Stationary general-purpose fluoroscopic x-ray system, analogue","722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722023, 722026, 722027, 722028, 722029, 722038",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251218_03"
Vk_20251218_03,2025-12-19,2026-01-22,"Added new language","Philips Medical Systems Nederland B.V.","Allura CV20","MD: Stationary angiographic x-ray system, digital",722031,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251218_03"
Vk_20260113_11,2026-01-21,2026-01-21,,"Baxter Healthcare SA","Oxiris Set GL, Oxiris Set ROW","MD: Haemofilter",973002,"See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260113_11"
Vk_20260113_11,2026-01-21,2026-01-21,,"Baxter Healthcare SA","PRISMAFLEX set","MD: Haemofilter","107144, 107636, 107640","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260113_11"
Vk_20250331_18,2026-01-21,2026-01-21,,"LSO Medical","Ringlight fiber","MD: Laser Surgery Instruments - Consumables",ORLF000003,L00117175,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250331_18"
Vk_20250331_18,2026-01-21,2026-01-21,,"LSO Medical","Ringlight Slim fiber","MD: Laser Surgery Instruments - Consumables",ORLF000005,L00113761,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250331_18"
Vk_20260105_56,2026-01-06,2026-01-21,"Added new language","Cardinal Health","Chest Drainage Units & accessories","MD: Drainage Systems With Reservoir","See FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260105_56"
Vk_20250826_37,2025-09-02,2026-01-21,"FSCA Part 2","Stryker Endoscopy","StrykeFlow 2","MD: Surgical irrigation/aspiration system pump","0250070500, 0250070520","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250826_37"
Vk_20251217_40,2025-12-18,2026-01-20,"Added new language","Permobil AB","Permobil M and F series with Corpus seating","MD: Electric-motor-driven wheelchair, occupant-controlled","M Corpus VS, M5 Corpus, M3 Corpus, F5 Corpus, F3 Corpus",,"428002070, 486000740, 486000739, 486000745, 492000920, 428002125, 428002124, 428002135, 428002132, 428002127, 428002126, 425001033, 492000924, 428002137",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251217_40"
Vk_20251229_34,2025-12-29,2026-01-20,"Added new language","Philips Medizinsysteme Böblingen GmbH","Patient Information Center iX","MD: Centralized patient monitor","866389, 866390",,,4.5.0,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251229_34"
Vk_20260115_13,2026-01-20,2026-01-20,,"Gyrus ACMI Inc.","ShockPulse-SE Lithotripsy System","MD: Ultrasonic lithotripsy system probe, reusable",EGSPL-SR,"See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260115_13"
Vk_20260115_13,2026-01-20,2026-01-20,,"Gyrus ACMI Inc.","ShockPulse Lithotripsy Generator","MD: Pneumatic/ultrasonic lithotripsy system",EGSPL-G,"See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260115_13"
Vk_20260115_28,2026-01-20,2026-01-20,,"Zimmer Surgical, Inc.","Zimmer Tourniquet Systems","MD: Surgical pneumatic tourniquet system","60500010100; 60320010100","See FSN","See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260115_28"
Vk_20260114_22,2026-01-20,2026-01-20,,"Gyrus ACMI Inc.","Vizishot 2 FLEX","MD: Endoscopic ultrasound-guided aspiration needle","NA-U403SX-4019; EGNA-U403SX4019",All,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260114_22"
Vk_20260114_16,2026-01-20,2026-01-20,,"Medline International France SAS","Sterile Surgical Gowns","MD: Surgical gown, single-use","see FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260114_16"
Vk_20260114_16,2026-01-20,2026-01-20,,"Medline International France SAS","Sterile surgical drapes","MD: Patient surgical drape, single-use","see FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260114_16"
Vk_20260108_09,2026-01-13,2026-01-19,"Added new language","Philips Medical Systems Nederland B.V.","Philips CT systems","MD: Full-body CT system","728306, 728307, 729332, 728333, 728334, 728340, 728344",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260108_09"
Vk_20251016_09,2025-10-23,2026-01-19,"Added new language","Gyrus ACMI Inc.","ShockPulse Lithotripsy Transducer","MD: Pneumatic/ultrasonic lithotripsy system","see FSN",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251016_09"
Vk_20251114_20,2025-11-18,2026-01-16,"correction affected products and lots","Avantor Performance Materials Poland S.A.","Formaldehyde solution, 10% V/V histo grade","IVD: Fixing Reagents (histology/cytology)","3059.9010PC; 3900; 3970; 3933.5000PC; 3933.9010; 3933.9020; 3963ME; 4078.9010; 4078.9020","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251114_20"
Vk_20251229_70,2026-01-07,2026-01-16,"New FSN with additional Devices","Vortex Surgical Inc.","25GA ACTU8 Forceps Pro-Grip","MD: Ophthalmic laser system beam guide",VS0713.25,2410050,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251229_70"
Vk_20251229_70,2026-01-07,2026-01-16,"New FSN with additional Devices","Vortex Surgical Inc.","25GA ACTU8 Forceps Pro-Grip","MD: Ophthalmic laser system beam guide",VS0713.25,2411011,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251229_70"
Vk_20251229_70,2026-01-07,2026-01-16,"New FSN with additional Devices","Vortex Surgical Inc.","25GA ACTU8 Forceps ILM -Myopic","MD: Ophthalmic laser system beam guide",VS0744.25-35,2410059,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251229_70"
Vk_20251229_70,2026-01-07,2026-01-16,"New FSN with additional Devices","Vortex Surgical Inc.","23G Laser Probe OS4 Flex-Tip","MD: Ophthalmic laser system beam guide",VK401113,2410031,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251229_70"
Vk_20251229_70,2026-01-07,2026-01-16,"New FSN with additional Devices","Vortex Surgical Inc.","23G Laser Probe OS4 Illuminated Flex-Tip","MD: Ophthalmic laser system beam guide",VK401213,2410034,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251229_70"
Vk_20251229_70,2026-01-07,2026-01-16,"New FSN with additional Devices","Vortex Surgical Inc.","25G Laser Probe OS4 Flex-Tip","MD: Ophthalmic laser system beam guide",VK401115,"2410058, 2410032, 2411022",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251229_70"
Vk_20251229_70,2026-01-07,2026-01-16,"New FSN with additional Devices","Vortex Surgical Inc.","25G Laser Probe OS4 Illuminated Flex-Tip","MD: Ophthalmic laser system beam guide",VK401215,2410035,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251229_70"
Vk_20251229_70,2026-01-07,2026-01-16,"New FSN with additional Devices","Vortex Surgical Inc.","23G Laser Probe OS4 Intuitive Extendable","MD: Ophthalmic laser system beam guide",VK401323,2410033,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251229_70"
Vk_20251229_70,2026-01-07,2026-01-16,"New FSN with additional Devices","Vortex Surgical Inc.","25G Laser Probe OS4 Intuitive Extendable","MD: Ophthalmic laser system beam guide",VK401325,2412025,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251229_70"
Vk_20251229_70,2026-01-07,2026-01-16,"New FSN with additional Devices","Vortex Surgical Inc.","27G Laser Probe OS4 Intuitive Extendable","MD: Ophthalmic laser system beam guide",VK401327,2411021,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251229_70"
Vk_20251218_38,2026-01-13,2026-01-15,"Added new language","Mint Medical GmbH","Mint Lesion","MD: Radiology Instruments - Software Accessories",,,,"Version 3.4.2 to Version 3.11.1","https://fsca.swissmedic.ch/mep/#?q=Vk_20251218_38"
Vk_20260108_03,2026-01-14,2026-01-14,,"Sysmex Corporation","Automated Hematology Analyser XN-Series","IVD: Haematology analyser","XN-10; AP795756",,"49687, 47085","see FSN","https://fsca.swissmedic.ch/mep/#?q=Vk_20260108_03"
Vk_20260112_20,2026-01-14,2026-01-14,,"Olympus Winter & Ibe GmbH","Resection sheath; Inner Sheath; Sheath","MD: Resectoscopes","A22014A, A22014T, A22041A, A22041T, A22042A, A22042T, A22043A, A22043T, A2666, A2666T, A42011A, A22040A, A22040T, A2660, A2660T, A4741, A2641, A2642, WA22017A, WA22017T, A37004A",All,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260112_20"
Vk_20260109_01,2026-01-14,2026-01-14,,"Medartis AG","TriLock Screw 16mm, HD7, 1/Pkg","MD: Bone Fixation Screws, Tendon And Ligament Synthesis Screws","A-5750.16/1, A-5850.16/1","25472432, 25467933",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260109_01"
Vk_20260107_02,2026-01-14,2026-01-14,,"Immucor, Inc.",Checkcell,"IVD: Coombs Control Cells",0002224/0002225,43257,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260107_02"
Vk_20251217_04,2025-12-19,2026-01-14,"Added new language","Philips Medical Systems Nederland B.V.","Philips Azurion system","MD: Stationary angiographic x-ray system, digital","722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228, 722280 , 722281, 722282",,,"R2.1.10 and R2.2.10","https://fsca.swissmedic.ch/mep/#?q=Vk_20251217_04"
Vk_20251217_26,2025-12-19,2026-01-14,"Added new language and content patient risk","CareDx AB","Olerup QTYPE 11","IVD: Hla Antigen Typing","201.701-10, 201-701-03","E073, E074, E075, E076, E077, E078, E079, E080, E081",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251217_26"
Vk_20251216_40,2025-12-19,2026-01-14,"Added new language","Philips Medical Systems Nederland B.V.","Philips Azurion system","MD: Stationary angiographic x-ray system, digital","722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228, 722229, 722230, 722231, 722232, 722233, 722234, 722235, 722236",,,R3.1,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251216_40"
Vk_20251203_21,2025-12-09,2026-01-13,"Added new language","RaySearch Laboratories AB",RayStation,"MD: Various Radiotherapy And Radiosurgery Instruments - Software Accessories","10B, 10B SP1, 11A, 11A SP1, 11A SP2, 11A SP3, 11B, 11B SP1, 11B SP2, 11B SP3, 11B SPT1, 12A, 12A SP1, 12A SP2, 2023B, 2024A, 2024A SP1, 2024A SP2, 2024A SP3, 2024B, v2025, v2025 SP1",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251203_21"
Vk_20260112_16,2026-01-13,2026-01-13,,"ICU Medical, Inc.","Tego Connector","MD: Haemodialysis tubing valve-connector",,"see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260112_16"
Vk_20260112_18,2026-01-13,2026-01-13,,"Bard Access Systems Inc","Broviac Catheter","MD: Centrally-inserted central venous catheter","Refer to the FSN","Refer to the FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260112_18"
Vk_20260112_18,2026-01-13,2026-01-13,,"Bard Access Systems Inc","Hickman Catheter","MD: Centrally-inserted central venous catheter","Refer to the FSN","Refer to the FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260112_18"
Vk_20260106_18,2026-01-13,2026-01-13,,"Olympus Medical Systems Corp.","Single Use Electrosurgical Knife","MD: Endoscopic electrosurgical handpiece/electrode, monopolar, single-use","KD-645L, KD-640L; N5412530, N2119630",all,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260106_18"
Vk_20240530_22,2024-06-11,2026-01-09,"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_22,2024-06-11,2026-01-09,"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_20251229_15,2026-01-06,2026-01-06,,"WAK-Chemie Medical GmbH","CryoSure-DMSO 6 x 70 ml Vials","MD: Blood storage solution, freezing",WAK-DMSO-70,USP23F1,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251229_15"
Vk_20251210_02,2025-12-22,2026-01-06,"Added new language","Instrumentation Laboratory Co.","HemosIL SynthAFax","IVD: Activated partial thromboplastin time (APTT) IVD, kit, clotting",0020007400,"N0542231; N0250088; N0452249",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251210_02"
Vk_20250806_22,2025-08-19,2026-01-06,"extended to include all Sterile Medihoney products currently on the market","Derma Sciences","MediHoney® - Gel Tubes","MD: Wound-nonadherent dressing, permeable, antimicrobial",405/793/794/795/796/797,"All unexpired lots",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250806_22"
Vk_20250806_22,2025-08-19,2026-01-06,"extended to include all Sterile Medihoney products currently on the market","Derma Sciences","MediHoney® - Dressings","MD: Medical honey liquid barrier dressing","391 - 395 - 398","All unexpired lots",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250806_22"
Vk_20260106_02,2026-01-06,2026-01-06,,"Olympus Medical Systems Corp.",Thunderbeat,"MD: Electrosurgical handpiece, single-use","TB-0535FCS, TB-0545FCS, TB-0520FCS, TB-0535PC, TB-0520IC, TB-0510IC; EGTB-0535FCS, N5423630, N5423730, EGTB-0545FCS, N5423330, N5423430, N5423930, N5424030 , N3810430, N3810730 , N3810830","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20260106_02"
Vk_20251215_01,2025-12-22,2026-01-05,"Added new language","Zhonghong Pulin Medical Co., Ltd.","Bal Protect Nitril Basic Sense Blue","MD: Nitrile examination/treatment glove, non-powdered, non-antimicrobial","Size: XS, S, M, L, XL","ZJ2306GA02, ZJ2306GA03",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251215_01"
Vk_20250715_01,2025-07-28,2026-01-05,"2. information for users with a hacked version that did receive the in-app message","Dexcom, lnc.","Dexcom G7 CGM App","MD: Percutaneous interstitial fluid glucose monitoring system, electrochemical","SW12299, SW12300, SW13355",,,"2.8.0 and earlier","https://fsca.swissmedic.ch/mep/#?q=Vk_20250715_01"
Vk_20251104_31,2025-11-19,2026-01-05,"FSN with new info","Philips Ultrasound, Inc.","Philips- Lumify Diagnostic Ultrasound system","MD: General-purpose ultrasound imaging system",,,,"iOS based devices","https://fsca.swissmedic.ch/mep/#?q=Vk_20251104_31"
Vk_20251209_34,2025-12-30,2025-12-30,,"Philips Medical Systems Nederland B.V.","Philips Azurion system","MD: Stationary angiographic x-ray system, digital","722229, 722230, 722231, 722232, 722233, 722234, 722235, 722236",,"See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251209_34"
Vk_20251222_40,2025-12-30,2025-12-30,,"Philips Goldway (Shenzhen) Industrial Inc.","Efficia DFM 100","MD: Physiologic-monitoring defibrillation system",866199,,,2.00.33,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251222_40"
Vk_20251229_10,2025-12-29,2025-12-29,,Barco,Barco,"MD: Various Digital Bioimaging Management Instruments - Other","MNA-420, MNA-440",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251229_10"
Vk_20251229_74,2025-12-29,2025-12-29,,"Beckman Coulter , Inc.","CellMek SPS","IVD: Various Sample Processing Instruments","C44603, D27513",,,2.3.90.0,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251229_74"
Vk_20251229_85,2025-12-29,2025-12-29,,"MAQUET Cardiopulmonary GmbH","Bubble Sensor BS 3/8x3/32 L1.7","MD: Cardiopulmonary bypass system air bubble/fluid level detector","701055720; 701055720",,"All serial numbers are potentially affected",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251229_85"
Vk_20251219_32,2025-12-23,2025-12-23,,"Meierhofer Medizintechnik",M-Medikation,"MD: Various Instruments For Functional Exploration And Therapeutic Interventions - Medical Device Software",,,,4.x.x,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251219_32"
Vk_20251218_16,2025-12-23,2025-12-23,,"Vascutek Ltd","Thoraflex Hybrid","MD: Descending thoracic aorta endovascular stent-graft",,"see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251218_16"
Vk_20251218_16,2025-12-23,2025-12-23,,"Vascutek Ltd","Gelsoft Plus","MD: Synthetic vascular graft",,"see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251218_16"
Vk_20251218_16,2025-12-23,2025-12-23,,"Vascutek Ltd","Vascutek Gelweave","MD: Synthetic vascular graft",,"see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251218_16"
Vk_20251219_01,2025-12-23,2025-12-23,,"Boston Scientific Corporation","AXIOS Stent and Delivery System","MD: Implantable transenteric drainage tube","M00553520, M00553530, M00553560, M00553680, M00553690","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251219_01"
Vk_20251223_01,2025-12-23,2025-12-23,,"Optimed Medizinische Instrumente GmbH","Tentos 4F","MD: Peripheral artery stent, bare-metal","see attached list","see attached list",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251223_01"
Vk_20250314_32,2025-03-18,2025-12-23,"Resolution Atellica CI Analyser","Siemens Healthcare Diagnostics Inc.","Atellica CH Revised C-Reactive Protein (RCRP)","IVD: C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry",11537223,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250314_32"
Vk_20251201_04,2025-12-03,2025-12-22,"Added new language","Roche Diagnostics GmbH","Combur10 Test M","IVD: Urine Multi-constituent Test Strips (manual)",09587624190,84639701,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251201_04"
Vk_20251217_05,2025-12-22,2025-12-22,,"Intuitive Surgical Sàrl","ACCESS PORT KIT, WOUND RETRACTOR","MD: Laparoscopic multi-instrument access port, single-use","430073, 430075","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251217_05"
Vk_20251210_01,2025-12-22,2025-12-22,,"Roche Diagnostics GmbH","cobas c 703 analytical unit","IVD: Chemistry Analysers - High Routine (random Access Without Ise Mode Test/h > 1.200)",09502971001,,"All Serial numbers from 2401-01 onward",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251210_01"
Vk_20251217_21,2025-12-22,2025-12-22,,"Sysmex Corporation","Automated Tube Sorter TS-10","IVD: Various Hematology / Histology / Cytology Instruments - Hardware Accessories","TS-10; BN168792",,"11001-12305, 12307-12317","all versions before 00-18 (<00-18)","https://fsca.swissmedic.ch/mep/#?q=Vk_20251217_21"
Vk_20250624_19,2025-06-24,2025-12-19,,"Liko AB","Q-Link 13, Adapter kit LikoScale, and LIKO UNO 102 EE Mobile lift","MD: Mobile patient lifting system, electrically-powered","3156509, 3156232",,N/A,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250624_19"
Vk_20251212_31,2025-12-18,2025-12-18,,"Fysicon B.V.","DataLinQ (MDR Class I)","MD: Cardiology information system","DataLinQ 2PAD; 01075001",,"Software V4.1.1","DataLinQ 2PAD V4.1.1","https://fsca.swissmedic.ch/mep/#?q=Vk_20251212_31"
Vk_20251212_20,2025-12-18,2025-12-18,,"Aesculap AG","MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM","MD: Laparoscopic access cannula, reusable",FF399R,"52845401, 52849932, 52895187, 52908537, 52918102, 52989006",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251212_20"
Vk_20251209_21,2025-12-18,2025-12-18,,ENOVACOM,"GXD5 PACS","MD: Picture Archiving And Communication Systems",,,,"all versions inferior to 4.0.4.307","https://fsca.swissmedic.ch/mep/#?q=Vk_20251209_21"
Vk_20251128_15,2025-12-12,2025-12-17,"Update FSN","Merit Medical Systems, Inc.","basixCOMPAK Inflation Device","MD: Catheter/overtube balloon inflator, single-use","All Models",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251128_15"
Vk_20251210_44,2025-12-17,2025-12-17,,"FreiStil Tischlerei GmbH & Co. KG","LISA NE (NE = niedriger Einstieg)","MD: Beds, Fixed, Cradle, Pediatric",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251210_44"
Vk_20251127_16,2025-12-17,2025-12-17,,"ArcRoyal Ltd","MedNet Syringes in ArcRoyal procedure packs","MD: General-purpose syringe, single-use","see FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251127_16"
Vk_20251216_01,2025-12-16,2025-12-16,,"IMRIS Imaging, Inc.",HFD100,"MD: Various Neurology And Neurosurgery Instruments - Hardware Accessories","119629-000; 119629-000",N/A,10008416,N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251216_01"
Vk_20251203_25,2025-12-09,2025-12-16,"Added new language","Medtronic Inc.","Vanta LT Clinician Programmer Application","AIMD: Multiple active implantable device programmer",A71200,,All,"2.0.2465 and 2.0.2683","https://fsca.swissmedic.ch/mep/#?q=Vk_20251203_25"
Vk_20251212_23,2025-12-16,2025-12-16,,"Mazor Robotics Ltd.","Mazor X System","MD: Stereotactic Orthopaedic Surgery Systems",TPL0059,,All,"5.0.1, 5.1.2, 5.1.3","https://fsca.swissmedic.ch/mep/#?q=Vk_20251212_23"
Vk_20251124_23,2025-12-15,2025-12-15,,"Laerdal Medical AS","Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 - RTCA)","MD: Emergency airway clearance suction system, electric",,"880052, 88005227, 880062, 88006227, 881152","See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251124_23"
Vk_20251118_01,2025-12-15,2025-12-15,,"Paul Hartmann AG","CS Pack ENDO-VASCULAIRE P2 CPT","MD: Clinical Procedures Kits Not Included In Other Classes - Other",238781,"400335290; 400448297; 500104291",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251118_01"
Vk_20251203_04,2025-12-11,2025-12-11,,"Smith & Nephew, Inc.","BIOSURE REGENESORB 5x20mm interference Screw","MD: Bioabsorbable orthopaedic bone screw",72204389,51306803,N/A,N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251203_04"
Vk_20251203_04,2025-12-11,2025-12-11,,"Smith & Nephew, Inc.","BIOSURE HA 6x20mm inferference screw","MD: Bioabsorbable orthopaedic bone screw",72201768,51315219,N/A,N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251203_04"
Vk_20251127_33,2025-12-11,2025-12-11,,"Heraeus Medical GmbH","PALACOS® R+G pro, PALACOS® MV+G pro, COPAL® G+Cpro","MD: Orthopaedic Prostheses Cements And Accessories For Mixing ","5081273, 5081279, 5081280, 5081281, 5081282, 5081283, 5081284, 5081285","all batches",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251127_33"
Vk_20251120_34,2025-12-11,2025-12-11,,"Agfa NV","DR 800","MD: Digital Remote Control Tables",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251120_34"
Vk_20251204_23,2025-12-10,2025-12-10,,"arcomed ag",UniQueDOC,"MD: Instruments Rack","5412-5418 and 5310 + 5412-5418","all device manufactured between 1.12.2023 and 30.06.2024","In Switzerland:, 20000002, 20000003, 20000004, 20000005, 20000055, 20000059, 20000060, 20000061, 20000062, 20000200, 20000317, 20000320, 20000400, 20000401, 20000402, 20000403, 20000420, , D1106541, D1116307, D1116308, D1116309, D1116310, D1106604, D11066",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251204_23"
Vk_20251208_07,2025-12-09,2025-12-09,,"Medartis AG","APTUS Cannulated Screw","MD: Cannulated Screws","A-3430S, A-5282.16/1S, A-5882.34/1S","25465083, 25468397, 25467908",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251208_07"
Vk_20251203_03,2025-12-09,2025-12-09,,"Beckman Coulter , Inc.","UniCel Dxl 800","IVD: Chemiluminescent immunoassay analyser IVD","973100; A71456; A71457; A25288",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251203_03"
Vk_20251203_03,2025-12-09,2025-12-09,,"Beckman Coulter , Inc.","UniCel Dxl 600","IVD: Chemiluminescent immunoassay analyser IVD","A71460; A71461; A30260",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251203_03"
Vk_20251205_08,2025-12-09,2025-12-09,,"Medtronic Inc.","Abre Venous Self-expanding Stent System","MD: Non-stainless Steel Peripheral Vascular Bare Metal Stents ","AB9G12060090, AB9G12080090, AB9G12100090, AB9G14080090, AB9G14100090, AB9G14120090","C112511, C113253, C113795, C117416, C134478, C150325",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251205_08"
Vk_20251209_06,2025-12-09,2025-12-09,,"Microbiologics, Inc.","KWIK-STIK and LYFO DISK controls","IVD: Multiple bacteria species culture isolate identification control IVD, kit","0325P, 0325K, 0325L","325-120-1, 325-120-3, 325-120-4, 325-120-5, 325-120-6, 325-120-7",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251209_06"
Vk_20240214_26,2024-02-20,2025-12-08,Follow-up,"Datascope Corp.","Cardiosave Intra-Aortic Balloon Pump","MD: Intra-aortic balloon pump","0998-XX-0800-XX, 0998-UC-0800-XX",All,"All Cardiosave serial numbers distributed since March 6, 2012 to present and ongoing",D.01,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240214_26"
Vk_20251110_31,2025-11-11,2025-12-08,"Update FSN","Intuitive Surgical, Inc","IS4000 Surgical System","MD: Robotic surgical arm system",seeFSN,seeFSN,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251110_31"
Vk_20251110_31,2025-11-11,2025-12-08,"Update FSN","Intuitive Surgical, Inc","IS4200 Surgical System","MD: Robotic surgical arm system",seeFSN,"see FSN","see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251110_31"
Vk_20251120_29,2025-11-27,2025-12-05,"New distributor FSN","Abbott Diabetes Care Ltd","FreeStyle Libre 3","MD: Percutaneous interstitial fluid glucose monitoring system, electrochemical","See FSN","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251120_29"
Vk_20251120_29,2025-11-27,2025-12-05,"New distributor FSN","Abbott Diabetes Care Ltd","Freestyle Libre 3 Plus","MD: Percutaneous interstitial fluid glucose monitoring system, electrochemical","See FSN","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251120_29"
Vk_20251202_24,2025-12-04,2025-12-04,,"Lohmann & Rauscher GmbH & Co. KG","Procedure packs (Kitpack) with MedNet syringes","MD: EMDN=n.a.","282530, 302251","2507280092, 2436580039, 2450480050",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251202_24"
Vk_20251117_27,2025-11-20,2025-12-03,"Added new language","Abbott Laboratories","Alinity ci-series System Control Module (SCM)","IVD: Automated Immunochemistry Analysers - Moderate Routine (throughput > 100 And <= 250 Test/h)",03R70-01,,"See Attachment A","Alinity ci SW v. 3.6.1 (04V20-28) and lower","https://fsca.swissmedic.ch/mep/#?q=Vk_20251117_27"
Vk_20251127_34,2025-12-03,2025-12-03,,"Philips Healthcare (Suzhou) Co., Ltd.","Incisive CT","MD: Full-body CT system","728143, 728144",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251127_34"
Vk_20251127_34,2025-12-03,2025-12-03,,"Philips Healthcare (Suzhou) Co., Ltd.","CT 5300","MD: Full-body CT system",728285,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251127_34"
Vk_20251201_06,2025-12-02,2025-12-02,,"GE Healthcare GmbH","Viewpoint 6","MD: Radiological PACS software",,,,"6.15.3, 6.15.4","https://fsca.swissmedic.ch/mep/#?q=Vk_20251201_06"
Vk_20251201_16,2025-12-02,2025-12-02,,"Remote Diagnostic Technologies Ltd.","Tempus Pro Patient Monitor","MD: Multiple vital physiological parameter monitoring system, clinical","00-1004, 00-1004-R, 00-1007, 00-1007-R, 00-1024-R, 00-1026-R",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251201_16"
Vk_20250501_01,2025-05-08,2025-12-02,"modification of the initial action plan","SC PRODUCTIONS","INDRA; LANIRA; BATEIA; HARMONIA","MD: Flotation therapy tank","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250501_01"
Vk_20251127_01,2025-12-02,2025-12-02,,"Cook Incorporated","Flexor Check-Flo Introducer","MD: Vascular catheter introduction set, nonimplantable","KCFW-10.0-35-45-RB-HFANL1-HC, KCFW-12.0-35-45-RB-HFANL0-HC, KCFW-12.0-35-45-RB-HFANL1-HC, KCFW-10.0-35-RB-RTPS-100, KCFW-9.0-38-70-RB-RAABE, KCFW-9.0-38-80-RB, KCFW-10.0-38-40-RB, KCFW-10.0-38-80-RB, KCFW-12.0-38-80-RB","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251127_01"
Vk_20251127_01,2025-12-02,2025-12-02,,"Cook Incorporated","Rösch-Uchida Transjugular Liver Access Sets","MD: Soft-tissue biopsy procedure kit, non-medicated",RUPS-100,"16659066, 16679321, 16681725, 16681726",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251127_01"
Vk_20251127_27,2025-12-02,2025-12-02,,"GE Healthcare Finland Oy","Multiple Patient Monitors and Portrait Vital Signs","MD: GMDN 33586: general-purpose multi-parameter bedside monitor &amp; GMDN 36872: multiple vital physiological parameter monitoring system, clinical","see FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251127_27"
Vk_20251119_22,2025-12-01,2025-12-01,,"Etac A/S","Molift Mover 205 and 300","MD: Overhead track patient lifting/transfer system","see FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251119_22"
Vk_20251119_21,2025-11-28,2025-11-28,,"Schiller Medical","SCHILLER DEFIGARD Touch7","MD: Physiologic-monitoring defibrillation system","DEFIGARD Touch7","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251119_21"
Vk_20230628_03,2023-07-10,2025-11-27,"New FSN","Ortho Clinical Diagnostics","ORTHO VISION Analyser","IVD: Blood group/antibody screening analyser IVD",6904579,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20230628_03"
Vk_20230628_03,2023-07-10,2025-11-27,"New FSN","Ortho Clinical Diagnostics","ORTHO VISION Max Analyser","IVD: Immunohaematology/blood bank analyser IVD",6904578,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20230628_03"
Vk_20251120_02,2025-11-26,2025-11-26,,"Roche Diagnostics GmbH","Elecsys Anti-TSHR","IVD: Tsh Receptor Antibodies","see FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251120_02"
Vk_20251120_01,2025-11-26,2025-11-26,,"ArcRoyal uc, an Owens and Minor Company","Ioban Drape in Cardiovascular Pack, Pack Cardio-va","MD: General surgical procedure kit, non-medicated, single-use","CH0509, 44-113746","815555, 822800, 814245, 816565, 819338, 821774, 822745, 823312, 824030",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251120_01"
Vk_20251118_22,2025-11-26,2025-11-26,,"CeMed GmbH","Pacco Anigiografia Moncucco","MD: Procedure pack, sterile",Co122865,"80625, 80713, 81847",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251118_22"
Vk_20251118_14,2025-11-26,2025-11-26,,TERENUI,Grimoires,"MD: General Medicine Therapeutic Treatment Instruments - Medical Device Software",,,"3.25. 20250925.5","3.25. 20250925.5","https://fsca.swissmedic.ch/mep/#?q=Vk_20251118_14"
Vk_20251118_10,2025-11-26,2025-11-26,,"N.G.C. Medical s.r.l",Prontopac,"MD: General surgical procedure kit, non-medicated, single-use",PP/CH-PFSZ-EMO1,"250602059; 250602296; 250702591",,N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251118_10"
Vk_20251119_28,2025-11-26,2025-11-26,,"Cepheid AB","Xpert BCR-ABL Ultra","IVD: Philadelphia chromosome/BCR-ABL mRNA expression IVD, kit, nucleic acid technique (NAT)","GXBCRABL-10; GXBCRABL-US-10",All,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251119_28"
Vk_20251120_44,2025-11-25,2025-11-25,,"Medtronic Inc.","Restore Clinician Programmer Application","MD: Neurostimulators Programmers - Software Accessories",A71100,,All,"Prior to 1.0.4489","https://fsca.swissmedic.ch/mep/#?q=Vk_20251120_44"
Vk_20250408_49,2025-04-16,2025-11-25,,Alchimia,"Got multi SF6","MD: gas container","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250408_49"
Vk_20250408_49,2025-04-16,2025-11-25,,Alchimia,"Got multi C3F8","MD: gas container","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250408_49"
Vk_20250408_49,2025-04-16,2025-11-25,,Alchimia,"Got multi C2F6","MD: gas container","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250408_49"
Vk_20251110_36,2025-11-11,2025-11-25,"Added new language","Kerr Italia S.r.l.","Hand Files: K-Flex, Triple-Flex, K-Files, Hedstrom","MD: Manual endodontic file/rasp, reusable","see FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251110_36"
Vk_20251113_01,2025-11-21,2025-11-21,,"Datascope Corp.","Cardiosave Intra-Aortic Balloon Pump","MD: Intra-aortic balloon pump","0998-XX-0800-XX; 0998-UC-0800-XX",All,"All Cardiosave serial numbers distributed since March 6, 2012 to present and ongoing.",D.01,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251113_01"
Vk_20251113_02,2025-11-21,2025-11-21,,"Datascope Corp.","Cardiosave Intra-Aortic Balloon Pump","MD: Intra-aortic balloon pump","0998-XX-0800-XX; 0998-UC-0800-XX",All,"All Cardiosave serial numbers distributed since March 6, 2012 to present and ongoing.",D.01,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251113_02"
Vk_20251106_02,2025-11-11,2025-11-20,"Added new language","Henry Schein Inc.","Henry Schein Maxima Diamond Bur FG","MD: Conservative Dentistry And Endodontics Devices - Other","See FSN","See FSN",,"Not applicable","https://fsca.swissmedic.ch/mep/#?q=Vk_20251106_02"
Vk_20241219_05,2024-12-19,2025-11-20,,"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_20251112_15,2025-11-18,2025-11-18,,"Beckman Coulter , Inc.","Access 2 Reaction Vessel","IVD: Samples Analyses, Plastic Containers",81901,"P243943, P243971, P244202 P244344, P244345, P250001, P250002, P250003, P250004 and P250005",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251112_15"
Vk_20251117_04,2025-11-18,2025-11-18,,"BK Medical ApS","Ultrasound system type 2300","MD: General-purpose ultrasound imaging system","bk3000, bk3500, bk5000, bkActiv Ultrasound Systems with battery: Model No. 2300-11; 2300-41; 2300-61; 2300-66; GTIN 05704916000264",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251117_04"
Vk_20251117_04,2025-11-18,2025-11-18,,"BK Medical ApS","Ultrasound system type 1300","MD: General-purpose ultrasound imaging system","bkSpecto Ultrasound Systems with battery: Model No. 1300-21 or 1300-S1, GTIN 05704916001285",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251117_04"
Vk_20251117_04,2025-11-18,2025-11-18,,"BK Medical ApS","Ultrasound system type 1202","MD: General-purpose ultrasound imaging system","Flex Focus Ultrasound Systems with battery: GTIN 05704916001056 and GTIN 05704916001087",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251117_04"
Vk_20210924_26,2021-10-13,2025-11-17,Ergänzung,"Datascope Corp.","Cardiosave Li-Ion Battery Pack","MD: Intra-aortic balloon pump",0146-00-0097,N/A,"see FSN",N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20210924_26"
Vk_20251024_14,2025-11-17,2025-11-17,,"Heraeus Medical GmbH","PALACOS® R+G pro 80 CE EUR","MD: Orthopaedic Prostheses Cements And Accessories For Mixing ",5081280,9019127269,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251024_14"
Vk_20251104_08,2025-11-11,2025-11-13,"Added new language","Philips Medical Systems Nederland B.V.","Zenition 10, Zenition 30","MD: Stationary angiographic x-ray system, digital","718401, 718076",,,"Not Applicable","https://fsca.swissmedic.ch/mep/#?q=Vk_20251104_08"
Vk_20251024_23,2025-11-13,2025-11-13,,"Roche Diagnostics GmbH","Electrolyte Analyzer","IVD: Ion Selective Electrolyte Analysers",03157334001,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251024_23"
Vk_20251104_34,2025-11-13,2025-11-13,,"BALT EXTRUSION SAS",HYBRID,"MD: Cardiac/peripheral vascular guidewire, single-use",HYBRID007D,00535219,N/A,N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251104_34"
Vk_20251110_05,2025-11-13,2025-11-13,,"Medicalgorithmics S.A.","Unified Arrhythmia Diagnostic System PocketECG IV","MD: Telemetric electrocardiographic ambulatory recorder",P4TR-CE-ADS,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251110_05"
Vk_20251110_05,2025-11-13,2025-11-13,,"Medicalgorithmics S.A.","Unified Arrhythmia Diagnostic System PocketECG III","MD: Telemetric electrocardiographic ambulatory recorder",P4TR-CE-ADS,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251110_05"
Vk_20251105_26,2025-11-11,2025-11-11,,"ICT Healthcare Technology Solutions (HCTS) B.V.","Mosos CTG","MD: Obstetrical monitoring/analysis software","see FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251105_26"
Vk_20251106_25,2025-11-11,2025-11-11,,"Elekta Solutions AB","Elekta Medical Linear Accelerator","MD: Medium And Multi Energy Linear Accelerators",,,"All Linear Accelerators (Synergy, Infinity, Versa HD, Elekta Evo) up to and including SN 157644, Harmony and Harmony Pro up to and including SN 451054",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251106_25"
Vk_20251110_23,2025-11-11,2025-11-11,,"Cepheid AB","Xpert HBV Viral Load","IVD: Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)",GXHBV-VL-CE-10,"Batch 1001446055 , Lot 30203",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251110_23"
Vk_20251106_11,2025-11-11,2025-11-11,,"Fresenius HemoCAre GmbH",CompoFlow,"MD: Blood donor set, quad-pack","see FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251106_11"
Vk_20251106_11,2025-11-11,2025-11-11,,"Fresenius HemoCAre GmbH",Composelect,"MD: Blood donor set, quad-pack","See FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251106_11"
Vk_20251020_29,2025-10-21,2025-11-07,"Added new language","DiaSorin Inc","LIAISON® C. difficile Toxins A&B","IVD: Clostridium difficile antigen IVD, kit, chemiluminescent immunoassay",318900,137454,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251020_29"
Vk_20251023_16,2025-11-07,2025-11-07,,"synedra information technologies GmbH","synedra View","MD: Radiology picture archiving and communication system",,,25.x,"25 Rhea","https://fsca.swissmedic.ch/mep/#?q=Vk_20251023_16"
Vk_20251024_02,2025-11-06,2025-11-06,,"CamDiab Ltd","mylife CamAPS","MD: General Medicine Therapeutic Treatment Instruments - Software Accessories",FX,,,"1.4(189) (Android), 1.4(192) (iOS) and earlier","https://fsca.swissmedic.ch/mep/#?q=Vk_20251024_02"
Vk_20251024_02,2025-11-06,2025-11-06,,"CamDiab Ltd",CamAPS,"MD: General Medicine Therapeutic Treatment Instruments - Software Accessories",FX,,,"1.4(189) (Android), 1.4(192) (iOS) and earlier","https://fsca.swissmedic.ch/mep/#?q=Vk_20251024_02"
Vk_20251029_40,2025-11-05,2025-11-05,,"Breas Medical AB","Clearway 2","MD: In-exsufflator",232000,,"See FSN","version 3.0.0 or earlier","https://fsca.swissmedic.ch/mep/#?q=Vk_20251029_40"
Vk_20251031_29,2025-11-05,2025-11-05,,"Renishaw Mayfield SARL","Neuromate control pedal","MD: Neurological stereotactic surgery system",001.0066,N/A,N/A,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251031_29"
Vk_20251028_34,2025-11-05,2025-11-05,,"Cepheid AB","Xpert CT/NG","IVD: Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)","GXCT/NG-10, GXCT/NG-120, GXCT/NG-CE-10, GXCT/NG-CE-120, GXCT/NG-CN-10, GXCT/NG-CN-120, GXCT/NG-JP-10, GXCT/NGX-CE-10, GXCT/NGX-CE-120",All,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251028_34"
Vk_20251103_34,2025-11-05,2025-11-05,,"DH Healthcare GmbH","ORBIS Medication 3.x","MD: General Medicine Instruments - Other",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251103_34"
Vk_20251029_24,2025-11-05,2025-11-05,,"Medtronic Inc.","Aurora EV-ICD MRI SureScan","AIMD: Single-chamber implantable defibrillator",DVEA3E4,,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251029_24"
Vk_20251031_31,2025-11-05,2025-11-05,,"Drägerwerk AG & Co. KGaA","ErgoStar, Dräger-Tubusverlängerungen","MD: Tracheal Tube Adapters","ErgoStar CM 40, ErgoStar CM 45, ErgoStar CM 55, ErgoStar CM 60","See FSN","See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251031_31"
Vk_20240606_13,2024-06-11,2025-11-05,,"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_20251029_23,2025-11-05,2025-11-05,,"ARKRAY, Inc.","SPOTCHEM D Electrolyte 25strips","IVD: Multiple-type clinical chemistry analyte profile IVD, reagent",77963,"D5D11, D5D12, D5E14, D5E15, D5F16",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251029_23"
Vk_20251103_40,2025-11-04,2025-11-04,,"Hill-Rom S.A.S.","Acella Therapy Air Mattress","MD: Alternating-pressure bed mattress system","P006789A, P006792A, P006793A, P006788A60001, P006788A60002, P006788A60004",,"All serial numbers HRPM10022464 to HRPM10029270",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251103_40"
Vk_20251031_39,2025-11-04,2025-11-04,,"SLE Ltd","SLE1500 & Interflow Gas Blender","MD: Neonatal CPAP unit","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251031_39"
Vk_20251103_18,2025-11-04,2025-11-04,,"Medtrade Products Ltd.","CELOX PPH","MD: Polysaccharide Haemostatic Dressings","FG08838281, FG08838171, FG08838291, FG08838321","All batches",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251103_18"
Vk_20240513_39,2024-05-16,2025-11-04,"Added new language","Philips Medical Systems Nederland B.V.","Height Adjustable (HA) FlexTrak Trolley","MD: Full-body MRI system, superconducting magnet","989710006411, 989710006412, 989710008732",,"See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240513_39"
Vk_20251104_01,2025-11-04,2025-11-04,,"Becton, Dickinson and Company","BD BACTEC MGIT 960 PZA Kit","IVD: Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit","Refer to FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251104_01"
Vk_20251017_18,2025-10-21,2025-11-03,"Added new language","HUMAN Gesellschaft für Biochemica und Diagnostica mbH",Autocal,"IVD: Calibrators Multicomponent (CC)",13160,0019,,n.a.,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251017_18"
Vk_20250923_14,2025-11-03,2025-11-03,,"Abbott Laboratories","Alinity hq Analyzer","IVD: Haematological cell analyser IVD",09P68-01,,"see FSN","5.0, 5.1, 5.4, 5.6, 5.8, 5.8.1, 5.10, 5.10.1","https://fsca.swissmedic.ch/mep/#?q=Vk_20250923_14"
Vk_20251024_19,2025-10-28,2025-11-03,"Added new language","Pulmodyne, Inc.",DART,"MD: Atomizer, non-ventilatory","DART100, DART110, DART140, DART300","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251024_19"
Vk_20251015_54,2025-10-29,2025-10-29,,"Abbott Medical","HeartMate II and HeartMate 3 System Controllers","MD: Implantable ventricular circulatory assist system control unit","106017, 106524INT, 106531INT, 106531LF2",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251015_54"
Vk_20251016_26,2025-10-29,2025-10-29,,"Schiller AG","EASY PULSE","MD: Cardiac Compressors","3.940409 , 3.940410; 0A.400000",-,-,1.1.3,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251016_26"
Vk_20251027_21,2025-10-28,2025-10-28,,"Illumina, Inc","CN NextSeq 550Dx HO Kit v2.5 (75 and 300 Cycles)","IVD: Nucleic acid sequencing reagent kit IVD","20028870 / 20028871",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251027_21"
Vk_20251027_21,2025-10-28,2025-10-28,,"Illumina, Inc","NextSeq 550Dx HO FC Cart v2.5 (75 & 300 cycles)","IVD: Nucleic acid sequencing reagent kit IVD","20031098 / 20026365",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251027_21"
Vk_20251022_17,2025-10-28,2025-10-28,,"Abbott Ireland Diagnostic Division","FreeGo Enteral Feeding Sets","MD: Enteral feeding noninvasive-component set","S790 / S795 / S810 / Y675","All Lot numbers",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251022_17"
Vk_20251027_28,2025-10-28,2025-10-28,,"Philips Healthcare (Suzhou) Co., Ltd.","Incisive CT","MD: Full-body CT system","728143, 728144, 728146, 728148, 728149, 728151, 728285, 728134, 728138, 728139",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251027_28"
Vk_20250417_20,2025-04-23,2025-10-28,"Update of FSN","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_20241029_01,2024-10-29,2025-10-28,"New information","Gambro Lundia AB","AK 98","MD: Haemodialysis system, institutional/home-use","115244, 115248, 115249, 115250, 955106, 955403, 955404, 955406, 955989",,"All serials lower than AK078305",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241029_01"
Vk_20251021_16,2025-10-28,2025-10-28,,"Cepheid AB","Xpert HIV-1 Viral Load XC","IVD: Hiv 1 - Na Reagents",GXHIV-VL-XC-CE-10,"1000796730; 13503",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251021_16"
Vk_20251022_31,2025-10-28,2025-10-28,,"GE ULTRASOUND Korea, Ltd","LOGIQ P9 and P10","MD: General-purpose ultrasound imaging system","LOGIQ P9 R4.5 system (PN 5877533); LOGIQ P10 R4.5 system (PN 5877534); LOGIQ P10 R4.5 HD system (PN 5877535)",,,R4.5.7,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251022_31"
Vk_20251024_20,2025-10-28,2025-10-28,,"Medtronic MiniMed","CareLink Clinic","MD: Patient health record information system application software",MMT-7350,,,"4.2A, 4.2.1A, 4.2B","https://fsca.swissmedic.ch/mep/#?q=Vk_20251024_20"
Vk_20250422_42,2025-04-29,2025-10-28,"Update of FSN","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_20251015_52,2025-10-28,2025-10-28,,"Sterisets Manufacturing S.A.","Citra-Lock S 4%","MD: Prefilled Syringes - Other",3591S2,"see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251015_52"
Vk_20251020_07,2025-10-27,2025-10-27,,"Sectra AB","Sectra Core","MD: Picture Archiving And Communication Systems","All supported versions",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251020_07"
Vk_20251003_07,2025-10-07,2025-10-24,"New additional information","IMRIS Imaging, Inc.","iMRI 3T S","MD: Magnetic Resonance (mr) Systems",116118-000,,10117-01,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251003_07"
Vk_20251014_17,2025-10-22,2025-10-22,,"Olympus Medical Systems Corp. Shinjuku Monolith","SnareMaster Plus Hot/Cold","MD: Endoscopic electrosurgical handpiece/electrode, monopolar, single-use","SD-400U-10, SD-400U-15; N5998230, N5998330","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251014_17"
Vk_20251020_32,2025-10-21,2025-10-21,,SEBIA,"CAPI 3 IMMUNOTYPING","IVD: Multiple clinical chemistry protein IVD, reagent",2600,"28075/50; 28075/51",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251020_32"
Vk_20251015_03,2025-10-21,2025-10-21,,"Olympus Medical Systems Corp.","EVIS EXERA III DUODENOVIDEOSCOPE","MD: Flexible video duodenoscope, reusable",TJF-Q190V,,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251015_03"
Vk_20251015_03,2025-10-21,2025-10-21,,"Olympus Medical Systems Corp.","EVIS LUCERA ELITE DUODENOVIDEOSCOPE","MD: Flexible video duodenoscope, reusable",TJF-Q290V,,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251015_03"
Vk_20251015_03,2025-10-21,2025-10-21,,"Olympus Medical Systems Corp.",Duodenovideoscope,"MD: Flexible video duodenoscope, reusable",TJF-Q170V,,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251015_03"
Vk_20251017_19,2025-10-21,2025-10-21,,"CellaVision AB","Automated Digital Cell Morphology Analyzer DI-60","IVD: Cell morphology analyser IVD, automated/semi-automated",CC286297,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251017_19"
Vk_20251015_04,2025-10-21,2025-10-21,,"Abbott Medical","CentriMag Blood Pump","MD: Cardiopulmonary bypass system centrifugal pump","201-90010, CMAEK01",,"All Serial Numbers",N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251015_04"
Vk_20250918_18,2025-10-20,2025-10-20,,"Ningbo KeRui Hygiene Product Co.,Ltd","Oral swab/Homedcare","MD: Oral care swab","GCP402-P(ME460201P), , GCP402-P20(ME460220P); GCP402","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250918_18"
Vk_20251014_01,2025-10-14,2025-10-20,,"Zimmer Biomet","G7 Acetabular System","MD: Acetabular shell","110031012; 110031013","Model number 110031012: 67160447, Model number 110031013: 67160480",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251014_01"
Vk_20251008_02,2025-10-15,2025-10-20,"List of affected serial numbers in Switzerland","Abbott Medical","Eterna SCS IPG","MD: Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable",32400,,"All SN shipped from launch (Dec. 2023) through October 8, 2024",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251008_02"
Vk_20251007_01,2025-10-13,2025-10-20,,"Shimadzu Corporation","Ceiling Tube Support CH-200","MD: X-ray system tube support, ceiling mounted",,,3ZC5C3B3B003,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251007_01"
Vk_20241011_20,2024-10-15,2025-10-20,"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_20,2024-10-15,2025-10-20,"additional information","Datex-Ohmeda Inc.","Giraffe OmniBed","MD: Conventional infant incubator",,,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241011_20"
Vk_20250219_20,2025-02-25,2025-10-20,"As the implementation of the changes to the IFU have now been conducted, the respective paragraph in the letter has been updated.","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_20251008_01,2025-10-17,2025-10-17,,"Cardinal Health","Salem Sump Stomach Tubes with Anti-Reflux Valve","MD: Nasogastric Tubes","See FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251008_01"
Vk_20250926_10,2025-10-10,2025-10-17,"Added new language","Abiomed Inc.","Automated Impella Controller (AIC)","MD: Intracardiac circulatory assist axial-pump catheter control unit","0042-0040; 0042-0040-EU",,"IC10382, IC10419, IC10681, IC10683","All AIC Software version","https://fsca.swissmedic.ch/mep/#?q=Vk_20250926_10"
Vk_20250820_24,2025-08-27,2025-10-16,"Added new language","Coloplast A/S","Elefant - Suction-irrigation device","MD: Minimally Invasive Surgery Cannulas, Single-use","see FSN","see FSN",,N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250820_24"
Vk_20251016_13,2025-10-16,2025-10-16,,"Avanos Medical, lnc.","Introducer Kit for Gastrostomy Feeding Tube","MD: Gastrostomy procedure kit","98430; 98431; 98432; 98433; 98434; 98701",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251016_13"
Vk_20251010_05,2025-10-15,2025-10-15,,"Etac Supply Center AB",Kaskad,"MD: Toilet Seats, Raised",80302012,,"100001 - 105600",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251010_05"
Vk_20251009_17,2025-10-15,2025-10-15,,"Microgenics Corporation, as part of Thermo Fisher Scientific","MAS Omni CARDIO","IVD: Cardiac Marker Controls","OCRD-L; OCRD-101; OCRD-202; OCRD-303; OCRD-SP; OCRD-MP; OCRD-UL","OCRD2704U; OCRD2704L; OCRD27041; OCRD27042; OCRD27043; OCRD2704S; OCRD2704M",N/A,N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251009_17"
Vk_20251009_23,2025-10-14,2025-10-14,,"BD Switzerland Sàrl","Alaris Syringe Pumps","MD: Bedside syringe pump","See FSN","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251009_23"
Vk_20251008_34,2025-10-14,2025-10-14,,"GE Medical Systems SCS","AW Server","MD: Radiological PACS software",,,,"Please see Field Safety Notice.","https://fsca.swissmedic.ch/mep/#?q=Vk_20251008_34"
Vk_20251008_28,2025-10-14,2025-10-14,,"OSATU Sociedad Cooperativa","REANIBEX 300","MD: Non-rechargeable public semi-automated external defibrillator",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251008_28"
Vk_20251008_28,2025-10-14,2025-10-14,,"OSATU Sociedad Cooperativa",REANIBEX500,"MD: Physiologic-monitoring defibrillation system",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251008_28"
Vk_20250925_19,2025-09-30,2025-10-10,"Added new language","Integra LifeSciences Corp","Codman Disposable Perforator","MD: Automatic cranial perforator, single-use","26-1222, 26-1223","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250925_19"
Vk_20251003_03,2025-10-09,2025-10-09,,"Dieter Marquardt-Medizintechnik GmbH","VITUS-Fi Distal Fibula Nail","MD: Nails, Bone","see FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251003_03"
Vk_20250926_23,2025-10-09,2025-10-09,,"PATH MEDICAL GmbH","MADSEN AccuScreen TEAOE/DPOAE/ABR Probe ; ","MD: Otoacoustic emission system, battery-powered","EP-DP / 8-69-41100",,"1008850 - 1009896",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250926_23"
Vk_20251006_29,2025-10-08,2025-10-08,,"Philips Medical Systems DMC GmbH","ProxiDiagnost N90","MD: Radiographic/fluoroscopic unit, mobile",706110,,"See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251006_29"
Vk_20251006_29,2025-10-08,2025-10-08,,"Philips Medical Systems DMC GmbH","CombiDiagnost R90","MD: Radiographic/fluoroscopic unit, mobile",709031,,"See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251006_29"
Vk_20251006_29,2025-10-08,2025-10-08,,"Philips Medical Systems DMC GmbH",DigitalDiagnost,"MD: Stationary basic diagnostic x-ray system, digital","712031; 712032; 712034; 712035",,"See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251006_29"
Vk_20251006_29,2025-10-08,2025-10-08,,"Philips Medical Systems DMC GmbH","Radiography 7300 C","MD: Radiographic/fluoroscopic unit, mobile",712037,,"See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251006_29"
Vk_20251003_16,2025-10-08,2025-10-08,,"Q'Straint","QRT-MAX Wheelchair Securement Retractor","MD: Wheelchairs Accessories - Other",Q8-6209,58957,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251003_16"
Vk_20251003_16,2025-10-08,2025-10-08,,"Q'Straint","QRT-DLX Wheelchair Securement Retractor","MD: Wheelchairs Accessories - Other",Q8-6200,58350,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251003_16"
Vk_20201218_18,2020-12-22,2025-10-08,"additional recommendations","HeartWare Inc.","HeartWare Ventricular Assist System - HVAD Pump Implant Kit","AIMD: Implantable ventricular circulatory assist system",1104,,all,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20201218_18"
Vk_20250923_17,2025-10-08,2025-10-08,,"HeartSine Technologies Ltd","HeartSine samaritan PAD","MD: Non-rechargeable public semi-automated external defibrillator","see FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250923_17"
Vk_20251006_17,2025-10-08,2025-10-08,,"THT BIO-SCIENCE",SWING-BAND,"MD: Abdominal/ENT/orthopaedic surgical probe, reusable","SB3 10400, SB3 10400 SP, SB3 10400 DG, SB3 10400 TO; SB4 10400, SB4 10400 DG, SB4 10400 SP, SB4 10400 TO",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251006_17"
Vk_20251001_05,2025-10-07,2025-10-07,,"Metrex Research LLC dba Orascoptic",Dragonfly,"MD: Surgical binoculars, reusable",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251001_05"
Vk_20251001_05,2025-10-07,2025-10-07,,"Metrex Research LLC dba Orascoptic",Phantom,"MD: Surgical binoculars, reusable",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251001_05"
Vk_20251003_22,2025-10-07,2025-10-07,,TERENUI,Grimoires,"MD: General Medicine Therapeutic Treatment Instruments - Medical Device Software",,,,3.25.20250825.2,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251003_22"
Vk_20251002_01,2025-10-07,2025-10-07,,"GE Medical Systems LLC","MAC VU360 Resting ECG Analysis System","MD: Electrocardiograph, professional, multichannel",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20251002_01"
Vk_20250929_43,2025-10-03,2025-10-03,,"DH Healthcare GmbH","ORBIS Medication 3.x","MD: General Medicine Instruments - Other",,,,"03.17.xx and higher","https://fsca.swissmedic.ch/mep/#?q=Vk_20250929_43"
Vk_20250926_20,2025-10-01,2025-10-01,,"Elekta Solutions AB","Leksell Vantage Arc System","MD: Neurological stereotactic surgery system",1040048,,SH00001-SH00338,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250926_20"
Vk_20250929_41,2025-10-01,2025-10-01,,"Philips Healthcare (Suzhou) Co., Ltd.","Incisive CT","MD: Full-body CT system","728143, 728144, 728146",,"See FSN","5.1.0.X and 5.1.1.X","https://fsca.swissmedic.ch/mep/#?q=Vk_20250929_41"
Vk_20250929_41,2025-10-01,2025-10-01,,"Philips Healthcare (Suzhou) Co., Ltd.","CT 5300","MD: Full-body CT system"," 728285",,"See FSN","5.1.0.X and 5.1.1.X","https://fsca.swissmedic.ch/mep/#?q=Vk_20250929_41"
Vk_20250923_23,2025-10-01,2025-10-01,,"MicroVention Europe S.A.R.L.","FRED & FRED X Flow Re-Direction Endoluminal Device","MD: Bare-metal intracranial vascular stent","FRED-X 27","0000663750, 0000704203",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250923_23"
Vk_20240517_06,2025-10-01,2025-10-01,,"Datascope Corp.","Cardiosave Intra-Aortic Balloon Pump","MD: Intra-aortic balloon pump",0998-XX-0800-XX,All,"All Cardiosave serial numbers distributed since March 6, 2012 to present and ongoing",D.01,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240517_06"
Vk_20250411_15,2025-04-16,2025-10-01,,"Philips Light & Health, Philips N.V.","IntelliSpace Cardiovascular","MD: Radiology picture archiving and communication system workstation",830089,,,"6.1, 6.2, 7.0, 7.1, and 8.0","https://fsca.swissmedic.ch/mep/#?q=Vk_20250411_15"
Vk_20250929_39,2025-09-30,2025-09-30,,"ConvaTec Limited","Natura+","MD: EMDN=31076",416417,4J01987,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250929_39"
Vk_20250926_28,2025-09-30,2025-09-30,,"Samsung Electronics Co., Ltd",GM85,"MD: Mobile basic diagnostic x-ray system, digital",GM85,"see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250926_28"
Vk_20250926_26,2025-09-30,2025-09-30,,"Beckman Coulter , Inc.","DxI 9000 Access Immunoassay Analyzer","IVD: Automated Immunochemistry Analysers - Moderate To High Routine (throughput > 250 And <= 700 Test/h)",,,,"1.22 and below","https://fsca.swissmedic.ch/mep/#?q=Vk_20250926_26"
Vk_20250926_26,2025-09-30,2025-09-30,,"Beckman Coulter , Inc.","DxC 500i Clinical Analyzer","IVD: Chemistry / Immunochemistry Instruments",,,,"1.3.5 and lower","https://fsca.swissmedic.ch/mep/#?q=Vk_20250926_26"
Vk_20250925_37,2025-09-30,2025-09-30,,"VOSS Healthcare GmbH","ello 2.0","MD: Walker/Chairs, Wheeled","ello_v02_55G and ello_v02_62G",N/A,all,"v2.3.1 and v2.3.2","https://fsca.swissmedic.ch/mep/#?q=Vk_20250925_37"
Vk_20250930_03,2025-09-30,2025-09-30,,"Biocomposites Ltd","Biosteon Screw","MD: Interference Screws","10MM X 35MM",BS240520,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250930_03"
Vk_20250929_09,2025-09-30,2025-09-30,,"GE Medical Systems Information Technologies, Inc.","Carescape Central Station","MD: Centralized patient monitor",,,,V3.0.5,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250929_09"
Vk_20230213_26,2023-02-20,2025-09-29,"implementing measures","Siemens Healthcare Diagnostics Products GmbH","Test Thrombin Reagent","IVD: Thrombin time (TT) IVD, kit, clotting",10446598,"see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20230213_26"
Vk_20250916_20,2025-09-24,2025-09-24,,"Samsara Vision Ltd.","SING IMT","MD: Intraocular telescope",,"11847, 11857, 11859, 11872, 11885, 11914, 11924, 11829, 11935, 11954, 11965",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250916_20"
Vk_20250917_12,2025-09-24,2025-09-24,,"Medtronic Sofamor Danek Inc.","Catalyft PL","MD: Metallic spinal interbody fusion cage","6068073, 6068076, 6068093, 6068096, 6068113, 6068116, 6069073, 6069076, 6069093, 6069096, 6069113, 6069116",All,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250917_12"
Vk_20250919_27,2025-09-23,2025-09-23,,"Beckman Coulter Biotechnology Co., Ltd.","DxFLEX Flow cytometer","IVD: Flow Cytometry Instruments",C44326,,"see FSN",V2.3.4.37,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250919_27"
Vk_20250912_07,2025-09-22,2025-09-22,,"Fisher & Paykel Healthcare Ltd","Airvo 2 Humidifier","MD: Professional high-flow respiratory unit, humidifying, manual",,"Last manufacture date: 5 August 2025, PT101EW GTIN - 09420012422286, PT100EW GTIN - 09420012422194",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250912_07"
Vk_20230309_12,2023-03-15,2025-09-22,"Minor Corrections, no new actions for Customers","Intuitive Surgical, Inc","Da Vinci X / Xi Surgical System","MD: Robotic surgical arm system","see FSN",,"see FSN","Not applicable","https://fsca.swissmedic.ch/mep/#?q=Vk_20230309_12"
Vk_20250912_16,2025-09-16,2025-09-22,"Added new language","Diagnostic Grifols SA","Erytra analyzer","IVD: Blood group/antibody screening analyser IVD",210400,,,"4.5.0 and 4.6.0","https://fsca.swissmedic.ch/mep/#?q=Vk_20250912_16"
Vk_20250905_22,2025-09-19,2025-09-19,,"Philips Medical Systems Nederland B.V.","Allura Xper","MD: Stationary general-purpose fluoroscopic x-ray system, analogue","722001, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722020, 722022, 722023, 722025, 722026, 722027, 722028, 722029, 722033, 722035, 722038, 722039, 722058, 722059",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250905_22"
Vk_20250905_22,2025-09-19,2025-09-19,,"Philips Medical Systems Nederland B.V.","Allura Centron","MD: Stationary general-purpose fluoroscopic x-ray system, analogue",722400,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250905_22"
Vk_20250905_22,2025-09-19,2025-09-19,,"Philips Medical Systems Nederland B.V.","Allura CV20","MD: Stationary angiographic x-ray system, digital",722031,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250905_22"
Vk_20250908_09,2025-09-19,2025-09-19,,"Philips Medical Systems Nederland B.V.","Allura Xper","MD: Stationary general-purpose fluoroscopic x-ray system, analogue","722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722020, 722022, 722023, 722025, 722026, 722027, 722028, 722029, 722033, 722035, 722038, 722039, 722058, 722059",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250908_09"
Vk_20250908_09,2025-09-19,2025-09-19,,"Philips Medical Systems Nederland B.V.","Allura CV20","MD: Stationary angiographic x-ray system, digital",722031,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250908_09"
Vk_20250915_51,2025-09-16,2025-09-18,"Added new language","Baxter Medical Systems GmbH + Co. KG","Charging unit mounted W/T AC TS7500","MD: Operating room equipment remote control",1451204,,"All products manufactured between May 12, 2009 and December 17, 2024",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250915_51"
Vk_20250911_01,2025-09-18,2025-09-18,,"Immucor, Inc.","Capture-R Ready Indicator Red Cells","IVD: Antibody Detection (immunohaematology) - Other",0006428,221880,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250911_01"
Vk_20250911_28,2025-09-18,2025-09-18,,"MAQUET Cardiopulmonary GmbH","Heater Unit HU35","MD: Cardiopulmonary bypass system heat exchanger, reusable","701072162, 701072163",N/A,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250911_28"
Vk_20250916_31,2025-09-17,2025-09-17,,"Cepheid AB","Xpert HBV Viral Load","IVD: Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)",GXHBV-VL-CE-10,17903/1001272175,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250916_31"
Vk_20250912_12,2025-09-17,2025-09-17,,"Abbott Medical","TactiFlex Force Sensing Ablation Catheter, SE","MD: Cardiac radio-frequency ablation system catheter","A-TFSE-D, A-TFSE-F, A-TFSE-FJ, A-TFSE-DF, A-TFSE-DD",All,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250912_12"
Vk_20250909_23,2025-09-17,2025-09-17,,"Beckman Coulter , Inc.","CellMek SPS","IVD: Various Sample Processing Instruments",C44603,All,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250909_23"
Vk_20250904_13,2025-09-16,2025-09-16,,"PAJUNK GmbH Medizintechnologie","StimuLong Sono II NanoLine","MD: Peripheral Nervous System Catheters And Kits","521187-32C, 531187-32A, 531187-32C","1590, 1590, 1591",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250904_13"
Vk_20250912_29,2025-09-16,2025-09-16,,"William Cook Europe ApS","ZENITH ALPHA 2 THORACIC ENDOVASCULAR GRAFT","MD: Synthetic vascular graft","See FSN","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250912_29"
Vk_20250910_02,2025-09-16,2025-09-16,,"MicroVention Europe S.A.R.L.","RENZAN Peripheral Stent System","MD: Peripheral artery stent, bare-metal","See FSN","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250910_02"
Vk_20250908_31,2025-09-09,2025-09-16,"Added new language","Diagnostica Stago","STA LIATEST DDI PLUS (IVDR Class C)","IVD: D-dimer IVD, kit, agglutination",00662,"271330 (Mfr date : 30/06/2024 - Exp date : 30/09/2025) , 271410 (Mfr date : 30/06/2024 - Exp date : 30/09/2025)",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250908_31"
Vk_20250911_30,2025-09-16,2025-09-16,,"Gloor AG","Medical gas pipeline systems","MD: Medical/medicinal Gas Pipeline Systems And Related Accessories",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250911_30"
Vk_20250825_35,2025-08-29,2025-09-15,"Added new language","DiaMed GmbH","ID-Anti-S, Test Serum ID-Anti-M, N, S, s, Fya, Fyb","IVD: EMDN=52648","007132, 008712","0033454701, 0050103803, 0076423804, 0076443805, 0076463806",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250825_35"
Vk_20250829_17,2025-09-02,2025-09-12,"Update FSN","credentis ag","Curodont Repair","MD: Dental coating, tooth-desensitizing, professional","80.0320; 80.0320 (P320)","- Lot CH240605, Lot CH240604, Lot CH240606",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250829_17"
Vk_20240521_54,2024-05-28,2025-09-12,"updated information","Stryker Orthopaedics","Mako Total Knee","MD: Stereotactic Orthopaedic Surgery Instruments - Software Accessories","700001590415, 700001590414, 700002190743-04, 700002190743-01, 700002190743-03, 700002190743-05",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240521_54"
Vk_20241213_03,2024-12-17,2025-09-11,"SW Update is now available; added new FSN language","Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation","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_20250901_14,2025-09-10,2025-09-10,,"XVIVO B.V","Liver Assist perfusion set","MD: Cardiosurgery And Organ Transplantation Devices - Other",11.401,"2507109, 2507099, 2510092, 2512114, 2512115, 2518114, 2518116, 2518115",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250901_14"
Vk_20250902_09,2025-09-09,2025-09-09,,"Neuromedex GmbH",MEDILOOPS,"MD: Tapes","01.2801, 01.2802, 01.2803, 01.2804, 01.2811, 01.2812, 01.2813, 01.2814, 01.2821, 01.2822","403010, 404118, 406001, 407272, 408246, 412061, 501100, 502078, 503001, 504061, 402019, 403011, 404119, 406002, 406230, 407273, 408247, 412062, 501101, 502079, 503002, 402020, 40412See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250902_09"
Vk_20250819_21,2025-08-26,2025-09-09,"Added new language","MedicalCommunications GmbH","Ashvins variant HEYEX 2/HEYEX PACS","MD: Ophthalmology PACS software",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250819_21"
Vk_20250903_27,2025-09-09,2025-09-09,,"Schiller Medical","DEFIGARD HD-7","MD: Physiologic-monitoring defibrillation system","DEFIGARD HD-7",,"between 130980000126 and 130980002352",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250903_27"
Vk_20250829_01,2025-09-09,2025-09-09,,"Maquet Cardiovascular, LLC","Heartstring III Proximal Seal System","MD: Intravascular anastomosis occluder","HS-3045, HSK-3038 & HSK-3043",,"All unexpired lots",N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250829_01"
Vk_20250909_01,2025-09-09,2025-09-09,,"Olympus Medical Systems Corp.","Flexible video bronchoscope, reusable","MD: Flexible video bronchoscope, reusable","see FSN",,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250909_01"
Vk_20250909_01,2025-09-09,2025-09-09,,"Olympus Medical Systems Corp.","Flexible fiberoptic bronchoscope","MD: Flexible fibreoptic bronchoscope","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250909_01"
Vk_20250909_01,2025-09-09,2025-09-09,,"Olympus Medical Systems Corp.","EVIS X1","MD: Data management system","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250909_01"
Vk_20250821_09,2025-08-27,2025-09-08,"Added summary of IFU changes in respective languages","W. L. Gore & Associates, Inc.","GORE ACUSEAL Vascular Graft","MD: Ptfe Vascular Prostheses, Straight, Reinforced","all Catalogue Numbers",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250821_09"
Vk_20250813_20,2025-09-04,2025-09-04,,"Dexcom, lnc.","Dexcom G6 iOS CGM App","MD: Percutaneous interstitial fluid glucose monitoring system, electrochemical","SW11585, SW11586",,,"1.11.2, 1.12.0","https://fsca.swissmedic.ch/mep/#?q=Vk_20250813_20"
Vk_20250827_01,2025-09-03,2025-09-03,,"Siemens Healthcare Diagnostics Inc.","Atellica CH Urinary/Cerebrospinal Fluid Protein","IVD: Total protein IVD, kit, enzyme spectrophotometry",11097543,"150287, 150225, 150091, 140456 (first IVDR lot number), 140359, 140302, 140301",N/A,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250827_01"
Vk_20250318_01,2025-03-26,2025-09-02,,"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_20250813_17,2025-09-02,2025-09-02,,"Weinmann Emergency Medical Technology GmbH + Co. KG","MEDUMAT Standard 2","MD: Transport electric ventilator","28710-01, 28710-02, 28710-03, 28710-04, 28944, 28590 / 29300, 29500, 9931, 9913, 9895, 9870, 9410, 9400","Devices with Firmware Version 5.7 or 5.9 (as of January 2025)",,"5.7 and 5.9","https://fsca.swissmedic.ch/mep/#?q=Vk_20250813_17"
Vk_20250819_01,2025-08-19,2025-09-01,"Added new language","Leica Biosystems Melbourne Pty Ltd","HistoCore PELORIS 3","IVD: Microscope slide stainer IVD","45.0001; 45.0001",,"45220604, 45220607",N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250819_01"
Vk_20250818_43,2025-09-01,2025-09-01,,"Stryker Instruments","Color Cuff® Sterile Disposable Tourniquet Cuffs","MD: GTIN=07613154599370 --- 07613154599257 -07613154599295","5921-024-235, 5921-018-135, 5921-018-235",2023121807,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250818_43"
Vk_20250825_34,2025-08-29,2025-08-29,,"ICU Medical Inc","CADD Medication Cassette Reservoir","MD: Infusion pump cassette","21-7001-24, 21-7002-24, 21-7300-24, 21-7301-24, 21-7302-24, 21-7600-24","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250825_34"
Vk_20250822_06,2025-08-28,2025-08-28,,"Jaeger Medical GmbH","Option Rhinomanometry, Option SNIP","MD: Pulmonary function analysis system, adult","V-578604, V-570304, V-578603, V-570303",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250822_06"
Vk_20250812_23,2025-08-28,2025-08-28,,"Shenzhen Mindray Bio-medical Electronics Co., Ltd.","Patient Monitor","MD: General-purpose multi-parameter bedside monitor","BeneVision N1",,"see FSN","02.02.01.01; 02.05.01.01; 02.19.00.01","https://fsca.swissmedic.ch/mep/#?q=Vk_20250812_23"
Vk_20250819_19,2025-08-26,2025-08-28,"Added new language","Medtronic Inc.","DLP Left Heart Vent Catheter","MD: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return","see FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250819_19"
Vk_20250827_02,2025-08-28,2025-08-28,,"LeMaitre Vascular, Inc","Artegraft Collagen Vascular Graft","MD: Vascular xenograft","AG630M, AG636M, AG730M, AG740M, AG845M",,"See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250827_02"
Vk_20250822_17,2025-08-27,2025-08-27,,"Drägerwerk AG & Co. KGaA","Atlan A350","MD: Anesthesia Units","8621100, 8621300, 8621400, 8621500, 8621600",,"ASUA-0472, ASUB-0095, ASUB-0243, ASUB-0245, ASUC-0228",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250822_17"
Vk_20250820_32,2025-08-27,2025-08-27,,"Exactech Inc.","Exactech Equinoxe Humeral Liners","MD: Polyethylene reverse shoulder prosthesis cup","See FSN",,"See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250820_32"
Vk_20250827_26,2025-08-27,2025-08-27,,"Liofilchem S.r.l","Imipenem 10ug IPM10","IVD: Multiple antimycobacterial susceptibility testing kit IVD",065048L,"See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250827_26"
Vk_20250731_20,2025-08-26,2025-08-26,,"GS Elektromedizinische Geräte G. Stemple GmbH",corpuls3,"MD: Physiologic-monitoring defibrillation system","04100, 04101, 04200, 04201, 04300, 04301",,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250731_20"
Vk_20250807_02,2025-08-15,2025-08-26,"Added new language","medin Medical Innovations GmbH",Medin-NC3,"MD: Neonatal CPAP unit",3000,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250807_02"
Vk_20250819_16,2025-08-26,2025-08-26,,"GE Healthcare","Enterprise Archive","MD: Radiological PACS software","see FSN",,,"Please see Field Safety Notice","https://fsca.swissmedic.ch/mep/#?q=Vk_20250819_16"
Vk_20250822_41,2025-08-26,2025-08-26,,"Philips Electronics Nederland B.V.","Brilliance CT","MD: Full-body CT system","see FSN",,860013,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250822_41"
Vk_20250822_07,2025-08-26,2025-08-26,,"B. Braun Melsungen AG","Drive complete PSP, green claws","MD: Bedside syringe pump","34521041, 34523142","92204627C5, 92204263C5, 97088136D5","98529, 98553, 98552, 98550, 98361, 98354, 98352, 98332, 98504, 98511, 98513, 98505",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250822_07"
Vk_20250815_06,2025-08-19,2025-08-22,"manufacturing and expiration date corrected","Contract Medical International GmbH","Blueflow Venous Stent devices","MD: Bare-metal peripheral venous stent","FG-02234-001A, FG-02234-002A, FG-02234-003A, FG-02234-004A, FG-02234-005A, FG-02234-006A, FG-02234-007A, FG-02234-008A, FG-02234-009A, FG-02234-010A; VS16150, VS16100, VS16060, VS14150, VS14100, VS14060, VS18100, VS18060, VS12100, VS12060","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250815_06"
Vk_20250815_10,2025-08-19,2025-08-21,"Added new language","Merit Medical Systems, Inc.","PhD Hemostasis Valve","MD: Haemostasis valve","See FSN","See FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250815_10"
Vk_20250818_40,2025-08-21,2025-08-21,,"Optimed Medizinische Instrumente GmbH","Tentos 4F","MD: Peripheral artery stent, bare-metal",7604-7040,"see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250818_40"
Vk_20250813_03,2025-08-19,2025-08-19,,"Alcon Laboratories, Inc.","Alcon Standalone Vitrectomy Consumables","MD: Ophthalmic surgical procedure kit, non-medicated, single-use",8065750957,"1877DC, 1788D1, 1790T0, 179LNP",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250813_03"
Vk_20250804_24,2025-08-18,2025-08-18,,"Philips Electronics Nederland B.V.","Philips Allura and Azurion","MD: Stationary angiographic x-ray system, digital","see FSN",,,"Azurion family (R1.X, R2.X), Allura family (R8.2)","https://fsca.swissmedic.ch/mep/#?q=Vk_20250804_24"
Vk_20250731_16,2025-08-15,2025-08-15,,"Vantive Health GmbH","TherMax Blood Warmer Unit","MD: Conduction blood/fluid warmer","955515, 955725, 955558",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250731_16"
Vk_20250731_16,2025-08-15,2025-08-15,,"Vantive Health GmbH","PRISMAX V3","MD: Haemodialysis system, institutional",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250731_16"
Vk_20250731_16,2025-08-15,2025-08-15,,"Vantive Health GmbH","PrisMax, V2 ROW","MD: Haemodialysis system, institutional",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250731_16"
Vk_20250606_15,2025-06-06,2025-08-14,,"Philips Medical Systems (Cleveland), Inc.","Pinnacle3 Radiation Therapy Planning System","MD: Radiation therapy software","870258, 870226, 870227, 870218, 870200",,,"18.0.5, 16.2, 16.2.1, 16.0.2, 14.0","https://fsca.swissmedic.ch/mep/#?q=Vk_20250606_15"
Vk_20250806_34,2025-08-14,2025-08-14,,"Dieter Marquardt-Medizintechnik GmbH",Vitus-Fi,"MD: Nails, Bone",09.63030.110S,25/175120,,"not applicable","https://fsca.swissmedic.ch/mep/#?q=Vk_20250806_34"
Vk_20250811_04,2025-08-14,2025-08-14,,"Gyrus ACMI Inc.","ViziShot 2 FLEX: Single Use Aspiration Needle","MD: General-purpose endoscopic needle, single-use","NA-U403SX-4019; EGNA-U403SX4019","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250811_04"
Vk_20230404_19,2023-04-13,2025-08-13,"Added new language","Elekta Limited","Elekta Unity","MD: Single Energy Linear Accelerators",All,,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20230404_19"
Vk_20250808_08,2025-08-13,2025-08-13,,"Beckman Coulter , Inc.","DxC 500i Clinical Analyzer","IVD: Chemistry / Immunochemistry Instruments","C13252, C63521, C63522",,,"1.3.3 and 1.3.4","https://fsca.swissmedic.ch/mep/#?q=Vk_20250808_08"
Vk_20250808_11,2025-08-13,2025-08-13,,"WINNCARE FRANCE","AXTAIR : Automorpho Plus, One Plus, Axensor AT12","MD: Alternating-pressure bed mattress system","VAXT4; VAXT2; VAXT6","Cells batch numbers: F2212236A, F2303333A","AXTAIR Serial numbers: See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250808_11"
Vk_20250806_03,2025-08-12,2025-08-12,,"Boston Scientific Corporation","Encore 26 Inflation Device","MD: Catheter/overtube balloon inflator, single-use","See FSN","See FSN","See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250806_03"
Vk_20250806_03,2025-08-12,2025-08-12,,"Boston Scientific Corporation","Encore 26 Advantage Kits, NephroMax Kits and UroMax Ultra Kits that contain impacted Encore 26 inflation devices","MD: Catheter/overtube balloon inflator, single-use","See FSN","See FSN","See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250806_03"
Vk_20250805_18,2025-08-12,2025-08-12,,"RaySearch Laboratories AB (publ)",RayStation,"MD: Various Radiotherapy And Radiosurgery Instruments - Software Accessories","6, 7, 8A, 8B, 9A, 9B, 10A, 10B, 11A, 11B, 2023A, 2023B, 2024A, ",,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250805_18"
Vk_20250808_13,2025-08-12,2025-08-12,,"Siemens Healthcare GmbH","ARTIS pheno","MD: Stationary angiographic x-ray system, digital","see FSN","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250808_13"
Vk_20250807_01,2025-08-12,2025-08-12,,"Agilent Technologies Singapore Pte Ltd.","FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26","IVD: CD20 cell marker IVD, antibody","GA60461-2, GA60461-2CN, GA60461-2J; GA604","41700704, 41810164, 41651581, 41762487, 41781549, 41741883, 41810156",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250807_01"
Vk_20250807_36,2025-08-12,2025-08-12,,"Schiller AG","ARGUS PB-3000","MD: Patient monitoring system module, multifunction","1A.701307, 3.921000, 3.921001, 3.921002, 3.921003, 3.921004, 3.921005, 3.921006, 3.921007, 3.921009, 3.921011, 3.921012, 3.921013, 3.921030, 3.921031",,"7010.000160 and lower, 7011.000356 and lower, 7012.000356 and lower, 7013.000256 and lower, 7014.000152 and lower",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250807_36"
Vk_20250805_19,2025-08-12,2025-08-12,,"Aesculap AG","SKULL TRACTION TONG LARGE","MD: Traction system skull tongs",FF870R,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250805_19"
Vk_20250725_14,2025-08-04,2025-08-08,"Added new language","Inogen Inc.","Inogen Rove 4 Portable Oxygen Concentrator","MD: Oxygen Concentrators",IS-401,,"25125119, 25125573, 25143912, 25143913, 25143922, 25143923, 25144249, 25133980, 25133982, 25133983",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250725_14"
Vk_20241024_39,2024-11-05,2025-08-08,"permanent solution now to be implemented","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_20241029_24,2024-11-05,2025-08-08,"permanent solution now to be implemented","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_24,2024-11-05,2025-08-08,"permanent solution now to be implemented","KayserBetten GmbH & Co. KG","KayserBett IDA","MD: Electrical assistive bed",IDA,,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20241029_24"
Vk_20250725_37,2025-08-07,2025-08-07,,"B. Braun Medical","Celsite Babyport","MD: Infusion/injection port, implantable",4433742,37038581,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250725_37"
Vk_20250804_33,2025-08-05,2025-08-07,"Added new language","Philips Healthcare Enterprise Imaging Informatics","Zenition 70","MD: Stationary general-purpose fluoroscopic x-ray system, digital",718133,"Not Applicable","4710, 4665, 4536","Not applicable","https://fsca.swissmedic.ch/mep/#?q=Vk_20250804_33"
Vk_20250805_22,2025-08-07,2025-08-07,,"QuidelOrtho (Ortho-Clinical Diagnostics Inc.)","VITROS Chemistry Products LAC Slides","IVD: Lactate IVD, reagent","8433880, 8150112","Coating 0160 and above",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250805_22"
Vk_20250804_45,2025-08-06,2025-08-06,,"Philips Medical Systems Nederland B.V.","Philips Allura Xper","MD: Stationary angiographic x-ray system, digital","see FSN",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250804_45"
Vk_20250804_08,2025-08-06,2025-08-06,,"Max Mobility LLC","SpeedControl Dial used with the Smartdrive MX2+","MD: Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible",MX2-3DC,,"All SpeedControl Dials",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250804_08"
Vk_20250725_36,2025-08-06,2025-08-06,,"Orthofix Srl","HALF PIN L120MM D4.0MM THREAD D4.0XL18MM PACK OF 2","MD: Orthopaedic bone pin, non-bioabsorbable",99-50-2511M,"B5332685; B5355666; B5398749; B5447654","Not applicable","Not applicable","https://fsca.swissmedic.ch/mep/#?q=Vk_20250725_36"
Vk_20250730_01,2025-08-05,2025-08-05,,"Boston Scientific Corporation","WATCHMAN Access sheath System","MD: Cardiac occluder delivery kit","see FSN","see FSN","see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250730_01"
Vk_20250715_30,2025-07-23,2025-08-04,"Added new language","Getinge - Maquet GmbH","CORIN operating table","MD: Universal operating table, electromechanical","770001A0, 770001A2, 770001B0, 770001B2, 770001F0, 770001F2",,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250715_30"
Vk_20250710_03,2025-07-15,2025-07-31,"Update FSN","Boston Scientific Neuromodulation Corporation","SureTek Burr Hole Cover Kit","MD: Deep brain electrical stimulation system","See FSN; See FSN","See FSN","See FSN",N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250710_03"
Vk_20250722_44,2025-07-31,2025-07-31,,"Baxter Medical Systems GmbH + Co. KG","TruSystem 7000","MD: Universal operating table, electromechanical","see FSN",,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250722_44"
Vk_20250725_35,2025-07-29,2025-07-31,"Added new language","Contract Medical International GmbH","Fortress Introducer Sheath System, 6F Straight 45c","MD: Cardiovascular Introducer Sheaths, Valved",386594,"800989 (only)",,N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250725_35"
Vk_20250722_48,2025-07-30,2025-07-30,,"Olympus Winter & Ibe GmbH","Electrosurgical Generator - ESG-410","MD: Electrosurgical Units",WA91307W,,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250722_48"
Vk_20250707_16,2025-07-10,2025-07-30,"Clarification of clinical actions","Becton Dickinson and Company","BD VACUTAINER Pronto Quick Release Needle Holder","MD: Blood collection tube holder, reusable",368872,"Refer to FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250707_16"
Vk_20250722_45,2025-07-29,2025-07-29,,"Medtronic Xomed Inc","POWEREASE Driver","MD: Various Ent Instruments - Other",2300000,,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250722_45"
Vk_20250725_04,2025-07-29,2025-07-29,,"Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation","ENDOTAK RELIANCE","AIMD: Pacemaker/defibrillator lead","See FSN","See FSN","See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250725_04"
Vk_20250725_17,2025-07-29,2025-07-29,,"Avanos Medical, lnc.",CORFLO,"MD: Nasogastric feeding tube","See FSN",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250725_17"
Vk_20250725_17,2025-07-29,2025-07-29,,"Avanos Medical, lnc.","CORTRAK 2","MD: Nasogastric feeding tube","See FSN",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250725_17"
Vk_20250714_02,2025-07-25,2025-07-25,"Acknowledge form","BioFire Diagnostics, LLC","BIOFIRE FILMARRAY TORCH","IVD: Thermal cycler nucleic acid amplification analyser IVD, laboratory","Shipping Configuration: HTFA-ASY-0001, Part Number: HTFAASY- 0104","All BIOFIRE FILMARRAY TORCH Base manufactured prior to September 16, 2024.",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250714_02"
Vk_20241127_03,2024-12-03,2025-07-25,"New Field Safety Notice","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_20250716_02,2025-07-24,2025-07-24,,"QuidelOrtho (Ortho-Clinical Diagnostics Inc.)","VITROS Chemistry Products Calcium Slides","IVD: Calcium (Ca2+) IVD, reagent",1450261,"GEN 67 and above",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250716_02"
Vk_20241218_28,2024-12-19,2025-07-23,,"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_20250718_24,2025-07-22,2025-07-22,,"Fresenius Kabi AG","Agilia Connect","MD: Infusion Pumps","Z0195XX, Z0196XX, Z0197XX",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250718_24"
Vk_20250717_35,2025-07-22,2025-07-22,,"Scanco Medical AG",XtremeCT,"MD: Various Instruments For Radiodiagnostics And Interventional Procedures",,,"see FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250717_35"
Vk_20250716_22,2025-07-22,2025-07-22,,"GE Medical Systems LLC and GE Healthcare (Tianjin) Company Limited","GE Healthcare (Tianjin) Company Limited: SIGNA Artist, SIGNA Artist Evo, SIGNA Voyager","MD: Full-body MRI system, superconducting magnet",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250716_22"
Vk_20250716_22,2025-07-22,2025-07-22,,"GE Medical Systems LLC and GE Healthcare (Tianjin) Company Limited","GE Medical Systems LLC: SIGNA Artist, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR","MD: Full-body MRI system, superconducting magnet",,,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250716_22"
Vk_20250606_08,2025-06-16,2025-07-21,"Added new language","Grifols Diagnostic Solutions Inc.","Procleix Parvo/HAV Assay","IVD: Hepatitis A/Parvovirus B19 virus nucleic acid IVD, kit, nucleic acid technique (NAT)","PRD-02816 PRD-02817 PRD-02818",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250606_08"
Vk_20231120_33,2023-11-21,2025-07-19,,"Philips Electronics Nederland B.V.","Philips Panorama 1.0T HFO","MD: Full-body MRI system, superconducting magnet","781250, 781350",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20231120_33"
Vk_20250704_25,2025-07-18,2025-07-18,,"Soluscope SAS","SOLUSCOPE SERIE 4","MD: Medical device disinfection agent","SL-V4-PA / SL-V4-SA-PA / SL-V4-RO-PA",,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250704_25"
Vk_20250205_21,2025-02-05,2025-07-17,,"Medtronic Inc.","Aortic Root Cannula","MD: Cardioplegia cannula","CFN 11014","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250205_21"
Vk_20250205_21,2025-02-05,2025-07-17,,"Medtronic Inc.","MiAR Cannulae","MD: Cardioplegia cannula","CFR 11012L; CFN 11014L","see FSN",,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250205_21"
Vk_20250703_24,2025-07-14,2025-07-17,"Added new language","SPINEART SA","CANNULATED FENESTRATED POLYAXIAL SCREW","MD: GMDN=07640305160561","MPF-PS 65 40-S",8-4528,,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250703_24"
Vk_20250704_12,2025-07-17,2025-07-17,,"Diagnostica Stago","STA Satellite® / STA Satellite Max®","IVD: Coagulation analyser IVD, laboratory","All references",/,"All serial numbers",/,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250704_12"
Vk_20250707_23,2025-07-08,2025-07-17,"Added new language","Philips Medical Systems Nederland B.V.","Allura Xper FD","MD: Stationary angiographic x-ray system, digital","722026, 722027, 722028, 722029, 722033, 722035, 722038, 722039, 722058, 722059",,,R8.2.x,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250707_23"
Vk_20220510_20,2022-05-17,2025-07-17,"Status Update","MAQUET Cardiopulmonary GmbH","Heater Unit HU35","MD: Cardiopulmonary bypass system heat exchanger, reusable","70103.5259; 70104.9090; 70107.2162; 70107.2163",,"All HU 35 units are affected since production start up to serial number 90039999 (HU 35, 230 V) and up to serial number 90035999 (HU35, 115 V)",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20220510_20"
Vk_20250708_02,2025-07-09,2025-07-14,,"Boston Scientific Corporation","Carotid Monorail Wallstent Endoprosthesis","MD: Coronary artery stent","See FSN","See FSN","See FSN",,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250708_02"
Vk_20240109_10,2024-01-17,2025-07-14,"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_20250711_15,2025-07-11,2025-07-11,,"bioMérieux Inc.","VITEK 2 - AST-N443 TEST KIT 20 CARDS","IVD: General-microorganism antimicrobial susceptibility culture medium IVD",424541,All,N/A,N/A,"https://fsca.swissmedic.ch/mep/#?q=Vk_20250711_15"
Vk_20240808_27,2024-08-13,2025-07-11,"additional information","Boston Scientific Neuromodulation Corporation","Vercise Genus","AIMD: Deep brain electrical stimulation system","M365DB12160, M365DB12320",,All,,"https://fsca.swissmedic.ch/mep/#?q=Vk_20240808_27"
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