Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.10.2022 – 31.12.2022

Німеччина

 

https://www.bfarm.de/EN/Medical-devices/Tasks/Risk-assessment-and-research/Field-corrective-actions/_node.html

https://www.bfarm.de/SharedDocs/Kundeninfos/DE/10/2022/29316-21_kundeninfo_de.pdf?__blob=publicationFile

Urgent Field Safety Notice for AION v3.0.1 by Nostos Genomics GmbH PDF, 323KB, File does not meet accessibility standards Date: 30. December 2022 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 33269/22

Urgent Field Safety Notice for LeukoSure Quantifizierungs-Kit by Beckman Coulter, Inc PDF, 1,013KB, File does not meet accessibility standards Date: 30. December 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – haematological, histological and cytological products
Reference 32374/22

Urgent Field Safety Notice for Ethanol Standard FS by DiaSys Diagnostic Systems GmbH PDF, 326KB, File does not meet accessibility standards Date: 29. December 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 34603/22

Urgent Field Safety Notice for Affinity Fusion Oxygenator mit integriertem arteriellen Filter und CVR by Medtronic Inc PDF, 873KB, File does not meet accessibility standards Date: 29. December 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 34245/22

Urgent Field Safety Notice for RUSCHELIT Super Safety Clear Tracheal Tube, oral/nasal, Murphy; Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff; Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; RUSCHELIT Safety Clear T by Teleflex (Perak West Malaysia) PDF, 3MB, File does not meet accessibility standards Date: 28. December 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 33575/22

Urgent Field Safety Notice for ARTIS pheno, ARTIS icono biplane/icono floor by Siemens Healthcare GmbH Advanced Therapies PDF, 275KB, File does not meet accessibility standards Date: 27. December 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology – radiological equipment for vascular diagnostics
Reference 33949/22

Urgent Field Safety Notice for Storage solution for blood platelets SSP+ by MacoPharma S.A. PDF, 657KB, File does not meet accessibility standards Date: 23. December 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – equipment for collecting blood products and peripheral stem cells
Reference 33559/22

Urgent Field Safety Notice for EXPRO Elite Snare by Vascular Solutions, Inc. PDF, 480KB, File does not meet accessibility standards Date: 23. December 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 34463/22

Urgent Field Safety Notice for Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e by Maquet Critical Care AB PDF, 236KB, File does not meet accessibility standards Date: 23. December 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 33970/22

Urgent Field Safety Notice for Meona, die elektronische Kurve by Meona GmbH PDF, 43KB, File does not meet accessibility standards Date: 22. December 2022 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 32366/22

Urgent Field Safety Notice for CEMENT PUSHER KIT by Safe Orthopaedics PDF, 348KB, File does not meet accessibility standards Date: 22. December 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – bone surgery
Reference 33664/22

Urgent Field Safety Notice for B125P/B105P/B125M/B105M/B155M Patient Monitor by GE Medical Systems Information Technologies, Inc. PDF, 505KB, File does not meet accessibility standards Date: 22. December 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 34443/22

Urgent Field Safety Notice for STATIF STU / STATIM STUM by Stephanix PDF, 304KB, File does not meet accessibility standards Date: 21. December 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology – stationary radiological equipment
Reference 29582/22

Urgent Field Safety Notice for Infinity Central Station (ICS) by Draeger Medical Systems, Inc PDF, 86KB, File does not meet accessibility standards Date: 21. December 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 34393/22

Urgent Field Safety Notice for iMedOne Medikation by Deutsche Telekom Clinical Solutions GmbH PDF, 151KB, File does not meet accessibility standards Date: 21. December 2022 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 31917/22

Urgent Field Safety Notice for i.s.h.med by Cerner Corporation PDF, 157KB, File does not meet accessibility standards Date: 21. December 2022 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 30918/22

Urgent Field Safety Notice for Druckmess-Set, single, 3 ml/h by Codan pvb Critical Care GmbH PDF, 492KB, File does not meet accessibility standards Date: 20. December 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electronic blood pressure monitor
Reference 31885/22

Urgent Field Safety Notice for Revaclear by Gambro Renal Products, Inc. PDF, 199KB, File does not meet accessibility standards Date: 20. December 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – dialysis technology
Reference 32163/22

Urgent Field Safety Notice for Idylla BRAF Mutation Test by Biocartis PDF, 1MB, File does not meet accessibility standards Date: 20. December 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 33948/22

Urgent Field Safety Notice for Microvit MT-101, MT-101 nano by Schiller AG PDF, 355KB, File does not meet accessibility standards Date: 20. December 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 32504/22

20. December 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 33538/22

Urgent Field Safety Notice for CritiCool by Belmont Instrument Corporation PDF, 464KB, File does not meet accessibility standards Date: 20. December 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 33980/22

Urgent Field Safety Notice for ProSet Infusions-Set by B. Braun Melsungen AG PDF, 164KB, File does not meet accessibility standards Date: 20. December 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 33185/22

Urgent Field Safety Notice for IMMULITE 2000 Thryoglobulin by Siemens Healthcare Diagnostics Products Ltd. PDF, 166KB, File does not meet accessibility standards Date: 20. December 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 33662/22

Urgent Field Safety Notice for G1 High Speed System Cleaning & Sterilization by The Anspach Effort, Inc. PDF, 471KB, File does not meet accessibility standards Date: 20. December 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – bone surgery
Reference 33264/22

Urgent Field Safety Notice for Artis zee/Q/Q.zen systems by Siemens Healthcare GmbH Advanced Therapies PDF, 842KB, File does not meet accessibility standards Date: 20. December 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology – radiological equipment for vascular diagnostics
Reference 33816/22

Urgent Field Safety Notice for Luminos dRF/Agile, dRF/Agile/Uroskop Omnia Max by Siemens Healthcare GmbH, X-Ray Products (XP) PDF, 351KB, File does not meet accessibility standards Date: 20. December 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology – stationary radiological equipment
Reference 33419/22

Urgent Field Safety Notice for therascreen FGFR RGQ RT-PCR Kit by QIAGEN GmbH PDF, 244KB, File does not meet accessibility standards Date: 20. December 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 33423/22

Urgent Field Safety Notice for ORTHO Optix Reader ORTHO BioVue Cassettes by Ortho-Clinical Diagnostics, Inc. PDF, 423KB, File does not meet accessibility standards Date: 19. December 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 30593/22

Urgent Field Safety Notice for QUATTROCONE30 implant by Medentika GmbH PDF, 542KB, File does not meet accessibility standards Date: 19. December 2022 Topics: Medical devices Type: Customer information

Product group Dental products – dental implants
Reference 33785/22

19. December 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 33799/22

Urgent Field Safety Notice for Autosoft 90 infusion set by Unomedical Infusion Devices A/S PDF, 423KB, File does not meet accessibility standards Date: 19. December 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 18122/22

Urgent Field Safety Notice for S.A.-IntraOperative-Intact PTH Immunoassay kit by Future Diagnostics Solutions B.V. PDF, 2MB, File does not meet accessibility standards Date: 19. December 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 33815/22

Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH PDF, 325KB, File does not meet accessibility standards Date: 16. December 2022 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 32236/22

Urgent Field Safety Notice for HAKEN-ELEKTRODE MONO 9CH 0° by Richard Wolf GmbH PDF, 1MB, File does not meet accessibility standards Date: 16. December 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrotherapy
Reference 33391/22

Urgent Field Safety Notice for M530 OHX, PROvido, Proveo 8 by Leica Microsystems (Schweiz) AG PDF, 967KB, File does not meet accessibility standards Date: 15. December 2022 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – medical microscopes (does not incude laboratory microscopes)
Reference 30678/22

Urgent Field Safety Notice for Sterile Produkte: Atraumatic Grasper, Maryland Dissector, Metzenbaum Scissors, Needle Holder, S. EU-0, S. EU-30, Sterile Cover Set, by avateramedical GmbH PDF, 688KB, File does not meet accessibility standards Date: 15. December 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – general instruments
Reference 32456/22

Urgent Field Safety Notice for ScleroSafe by VVT Medical Ltd. PDF, 463KB, File does not meet accessibility standards Date: 13. December 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – vascular surgery
Reference 33401/22

Urgent Field Safety Notice for Guarded Luer Connector (GLC) by International Medical Industries PDF, 2MB, File does not meet accessibility standards Date: 13. December 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 32720/22

Urgent Field Safety Notice for Mahurkar Acute Dual Lumen High Flow Catheter by Covidien llc PDF, 935KB, File does not meet accessibility standards Date: 12. December 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 33084/22

12. December 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 32431/22

Urgent Field Safety Notice for Einmalkanüle 22Gx100x7 by Inomed Medizintechnik GmbH, Emmendingen PDF, 871KB, File does not meet accessibility standards Date: 12. December 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – syringes and cannulas
Reference 31504/22

Urgent Field Safety Notice for 3M Ranger Blood/Fluid Warming High Flow Sets by 3M Company PDF, 451KB, File does not meet accessibility standards Date: 12. December 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – equipment for collecting blood products and peripheral stem cells
Reference 29861/22

Urgent Field Safety Notice for TRANSPORT MEDIUM by Vircell S.L. PDF, 250KB, File does not meet accessibility standards Date: 12. December 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – others
Reference 27017/22

Urgent Field Safety Notice for Novocastra by Leica Biosystems Newcastle Ltd PDF, 1MB, File does not meet accessibility standards Date: 10. December 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 33022/22

Urgent Field Safety Notice for RayOne EMV by Rayner Intraocular Lenses Limited PDF, 300KB, File does not meet accessibility standards Date: 10. December 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 33068/22

Urgent Field Safety Notice for NEONATAL, NASAL CANNULA WITH CURVED PRONGS AND TUBE, 2,1M by Intersurgical Ltd. PDF, 2MB, File does not meet accessibility standards Date: 10. December 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 33073/22

Urgent Field Safety Notice for Lubegel plus by Yasemin Medikal Malzemeleri Tic. San. A.S. PDF, 415KB, File does not meet accessibility standards Date: 09. December 2022 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – endoscopes
Reference 30578/22

Urgent Field Safety Notice for NexGen Option Stemmed Tibial Component by Zimmer Inc. PDF, 1MB, File does not meet accessibility standards Date: 09. December 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 33014/22

Urgent Field Safety Notice for Cranial Kit – No Drugs by INTEGRA Pain management PDF, 349KB, File does not meet accessibility standards Date: 08. December 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – neurosurgery
Reference 32177/22

08. December 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 33021/22

Urgent Field Safety Notice for Liquid Assayed Specific Protein Controls by Randox Laboratories Ltd PDF, 5MB, File does not meet accessibility standards Date: 08. December 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 32205/22

Urgent Field Safety Notice for custo cardio 400 BT; custo cardio 400 accu by custo med GmbH PDF, 110KB, File does not meet accessibility standards Date: 07. December 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 32876/22

Urgent Field Safety Notice for MEDUCORE Standard 2 by WEINMANN Emergency Medical Technology GmbH + Co. KG PDF, 174KB, File does not meet accessibility standards Date: 07. December 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrotherapy
Reference 28848/22

Urgent Field Safety Notice for Arrow AutoCAT Intra-Aortic Balloon Pump (IABP) Series, AC3T Series IABP System by Teleflex Medical USA PDF, 648KB, File does not meet accessibility standards Date: 07. December 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 30815/22

Urgent Field Safety Notice for ProSet Discofix C by B. Braun Melsungen AG PDF, 218KB, File does not meet accessibility standards Date: 07. December 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 32169/22

Urgent Field Safety Notice for DR-XD 1000 / FDR Nano by FUJIFILM Corporation PDF, 898KB, File does not meet accessibility standards Date: 06. December 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology – mobile radiological diagnostic facilities
Reference 32113/22

Urgent Field Safety Notice for Vanta LT Clinician Programmer Application by Medtronic Inc PDF, 1MB, File does not meet accessibility standards Date: 06. December 2022 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – programming and control equipment
Reference 32369/22

Urgent Field Safety Notice for HumaTex RF by HUMAN Gesellschaft für Biochemica und Diagnostica mbH PDF, 187KB, File does not meet accessibility standards Date: 06. December 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 32531/22

Urgent Field Safety Notice for SOPHIE by Fritz Stephan GmbH PDF, 455KB, File does not meet accessibility standards Date: 06. December 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 32619/22

05. December 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 31936/22

Urgent Field Safety Notice for Fetal Spiral Electrode by Philips Medical Systems PDF, 312KB, File does not meet accessibility standards Date: 05. December 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 32354/22

Urgent Field Safety Notice for Adhese Universal by Ivoclar Vivadent AG PDF, 157KB, File does not meet accessibility standards Date: 05. December 2022 Topics: Medical devices Type: Customer information

Product group Dental products – dental material
Reference 31258/22

Urgent Field Safety Notice for ALARIS GP by BD Switzerland Sarl PDF, 415KB, File does not meet accessibility standards Date: 02. December 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 32238/22

Urgent Field Safety Notice for Folienbeutel Nahtmaterialbeutel: Dermalon, Novafil, Surgilon, Surgipro, Ti-Cron by Covidien llc PDF, 462KB, File does not meet accessibility standards Date: 02. December 2022 Topics: Medical devices Type: Customer information

Product group Dressings / Pads – surgical sutures, vascular loops etc.
Reference 32495/22

Urgent Field Safety Notice for Ingenia Elition, MR 7700 by Philips Medical Systems Nederland B.V. PDF, 3MB, File does not meet accessibility standards Date: 01. December 2022 Topics: Medical devices Type: Customer information

Product group Electromedical fields – equipment for MR tomography
Reference 31507/22

Urgent Field Safety Notice for MYRIAN by Intrasense PDF, 1MB, File does not meet accessibility standards Date: 01. December 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine
Reference 31669/22

Urgent Field Safety Notice for Biopsy Forceps S. by Endo-Flex GmbH PDF, 325KB, File does not meet accessibility standards Date: 30. November 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – general instruments
Reference 32003/22

Urgent Field Safety Notice for Saug- und S.ülinstrumente by Dewimed Medizintechnik GmbH PDF, 255KB, File does not meet accessibility standards Date: 30. November 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – drainages and suction systems
Reference 30680/22

Urgent Field Safety Notice for Self-expanding – Stents S. by Endo-Flex GmbH PDF, 321KB, File does not meet accessibility standards Date: 30. November 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 32001/22

29. November 2022 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection – radiotherapy treatment planning systems
Reference 31881/22

Urgent Field Safety Notice for Liver Assist Perfusion Set by XVIVO B.V. PDF, 524KB, File does not meet accessibility standards Date: 29. November 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 31487/22

Urgent Field Safety Notice for AXIOM Iconos R100; R200 C20+C90; AXIOM Luminos TF by Siemens Healthcare GmbH Advanced Therapies PDF, 349KB, File does not meet accessibility standards Date: 29. November 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology – stationary radiological equipment
Reference 31024/22

Urgent Field Safety Notice for CM root canal posts Reamer (White) Post size 1 by Cendres & Métaux PDF, 193KB, File does not meet accessibility standards Date: 29. November 2022 Topics: Medical devices Type: Customer information

Product group Dental products – instruments
Reference 28364/22

Urgent Field Safety Notice for Centricity PACS IW by GE HEALTHCARE INTEGRATED IT SOLUTIONS Inc PDF, 258KB, File does not meet accessibility standards Date: 29. November 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine
Reference 30968/22

Urgent Field Safety Notice for Presage ST2 Assay by Critical Diagnostics PDF, 640KB, File does not meet accessibility standards Date: 29. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – haematological, histological and cytological products
Reference 19697/22

Urgent Field Safety Notice for ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE by Olympus Medical Systems Corp. PDF, 445KB, File does not meet accessibility standards Date: 29. November 2022 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – endoscopes
Reference 30430/22

Urgent Field Safety Notice for HUGO Bipolar Fenestrated Grasper by Covidien llc PDF, 177KB, File does not meet accessibility standards Date: 29. November 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 18670/22

Urgent Field Safety Notice for Glyde File Prep Doses Pack by Maillefer Instruments Holding SARL PDF, 524KB, File does not meet accessibility standards Date: 28. November 2022 Topics: Medical devices Type: Customer information

Product group Dental products – instruments
Reference 30102/22

Urgent Field Safety Notice for VACSII 22×40 Cardiac valvuloplasty catheter by OSYPKA AG PDF, 326KB, File does not meet accessibility standards Date: 28. November 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 31664/22

28. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 30542/22

Urgent Field Safety Notice for Sensis, Sensis Vibe Combo, Sensis Vibe Hemo by Siemens Healthcare GmbH, Advanced Therapies Angiographie PDF, 1MB, File does not meet accessibility standards Date: 25. November 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology – radiological equipment for vascular diagnostics
Reference 30639/22

Urgent Field Safety Notice for Guardian Connect Application by Medtronic Minimed PDF, 216KB, File does not meet accessibility standards Date: 25. November 2022 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 31266/22

Urgent Field Safety Notice for Catheter Repair Kits (Various) by Bard Access Systems Division (BASD) PDF, 473KB, File does not meet accessibility standards Date: 25. November 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 31492/22

Urgent Field Safety Notice for Atellica IM Free Prostate-Specific Antigen (fPSA) by Siemens Medical Solutions Diagnostics PDF, 179KB, File does not meet accessibility standards Date: 24. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 31473/22

Urgent Field Safety Notice for NextAR Shoulder System by Medacta International SA PDF, 666KB, File does not meet accessibility standards Date: 24. November 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 28629/22

Urgent Field Safety Notice for Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e by Maquet Critical Care AB PDF, 385KB, File does not meet accessibility standards Date: 23. November 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 29748/22

Urgent Field Safety Notice for Small Joint OATS Set Autograft Diameter 8 / 6 mm by Arthrex Inc. PDF, 694KB, File does not meet accessibility standards Date: 23. November 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – bone surgery
Reference 30389/22

Urgent Field Safety Notice for IMMULITE 2000, IMMULITE 2000XPi by Siemens Healthcare Diagnostics Ltd PDF, 267KB, File does not meet accessibility standards Date: 23. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 21027/22

Urgent Field Safety Notice for SYNGO RT THERAPIST in combination with ARTISTE MV by Siemens Healthcare GmbH, Advanced Therapies, Radiation Oncology PDF, 654KB, File does not meet accessibility standards Date: 23. November 2022 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection – radiotherapy treatment planning systems
Reference 30410/22

23. November 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 28258/22

Urgent Field Safety Notice for Elecsys CA 19-9 by Roche Diagnostics GmbH PDF, 131KB, File does not meet accessibility standards Date: 22. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 00936/20

Urgent Field Safety Notice for Dimension Vista Magnesium Flex reagent cartridge by Siemens Healthcare Diagnostics Inc. Newark PDF, 283KB, File does not meet accessibility standards Date: 22. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 03198/22

Urgent Field Safety Notice for VIDAS 3 System by BioMérieux SA PDF, 303KB, File does not meet accessibility standards Date: 21. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – instruments, apparatuses and systems
Reference 21068/22

Urgent Field Safety Notice for Drug-Screen 7-ACL 200 Test by nal von minden GmbH PDF, 456KB, File does not meet accessibility standards Date: 21. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 14834/22

Urgent Field Safety Notice for Ureter Catheter, Coaxial, No Eyes by Teleflex Medical Athlone PDF, 2MB, File does not meet accessibility standards Date: 21. November 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 29003/22

Urgent Field Safety Notice for cobas® 5800 Instrument by Roche Molecular Systems Inc. PDF, 590KB, File does not meet accessibility standards Date: 21. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 23118/22

Urgent Field Safety Notice for Mueller-Hinton-Agar by Axon Biotech GmbH PDF, 682KB, File does not meet accessibility standards Date: 21. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – microbiological products
Reference 16026/22

Urgent Field Safety Notice for IH-500 by Bio-Rad Laboratories, DiaMed GmbH PDF, 854KB, File does not meet accessibility standards Date: 21. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – instruments, apparatuses and systems
Reference 25516/22

Urgent Field Safety Notice for BD Veritor Plus System Analyzer by Becton, Dickinson and Company PDF, 1MB, File does not meet accessibility standards Date: 21. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 00668/22

21. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 18763/22

Urgent Field Safety Notice for Atellica CH Lithium_2 (LITH_2) + Atellica CH Lithium (Li) by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 159KB, File does not meet accessibility standards Date: 21. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 25699/22

Urgent Field Safety Notice for NEFA Unveresterte Fettsäuren by Labor+Technik Eberhard Lehmann GmbH PDF, 208KB, File does not meet accessibility standards Date: 21. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 20004/22

Urgent Field Safety Notice for ARCHITECT Hemoglobin A1c (A1c) and Alinity c Hemoglobin A1c (HbA1c) Reagent Kit by Abbott GmbH PDF, 150KB, File does not meet accessibility standards Date: 21. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 14362/22

Urgent Field Safety Notice for Alinity m System by Abbott Molecular, Inc PDF, 1MB, File does not meet accessibility standards Date: 21. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 28233/22

Urgent Field Safety Notice for X-CORE 2 Ti Core, Static by NuVasive, Inc. PDF, 578KB, File does not meet accessibility standards Date: 21. November 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 30545/22

Urgent Field Safety Notice for ACL TOP 3X0 CTS/ 5X0 CTS and refurb ACL TOP 970CL by Instrumentation Laboratory Company PDF, 849KB, File does not meet accessibility standards Date: 21. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – haematological, histological and cytological products
Reference 06774/22

Urgent Field Safety Notice for ORTHO Optix Reader ORTHO BioVue Cassettes by Ortho-Clinical Diagnostics, Inc. PDF, 393KB, File does not meet accessibility standards Date: 21. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 21154/22

Urgent Field Safety Notice for Polaris Multimedia by Drägerwerk AG & Co. KGaA PDF, 4MB, File does not meet accessibility standards Date: 21. November 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 29264/22

Urgent Field Safety Notice for Randox Cholesterol by Randox Laboratories Ltd PDF, 3MB, File does not meet accessibility standards Date: 21. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 15872/22

1. November 2022 Topics: Medical devices Type: Customer information

Product group ophthalmological technology – equipment for ophthalmological therapeutics
Reference 23763/22

Urgent Field Safety Notice for Cholestech LDX Test Cassettes by Alere San Diego, Inc. PDF, 186KB, File does not meet accessibility standards Date: 21. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 18262/22

Urgent Field Safety Notice for Mueller Hinton Agar by BioMérieux SA PDF, 717KB, File does not meet accessibility standards Date: 21. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – microbiological products
Reference 25681/22

Urgent Field Safety Notice for iChem VELOCITY Chemistry Strips by IRIS International PDF, 294KB, File does not meet accessibility standards Date: 21. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 19854/22

Urgent Field Safety Notice for BILIRUBIN liquicolor by HUMAN Gesellschaft für Biochemica und Diagnostica mbH PDF, 58KB, File does not meet accessibility standards Date: 21. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 25902/22

Urgent Field Safety Notice for Biosen Glucose/Lactate hemolyzing solution by EKF-diagnostic GmbH PDF, 1MB, File does not meet accessibility standards Date: 18. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 18923/22

Urgent Field Safety Notice for Angiographic Catheter Extensions by Cordis Corporation PDF, 477KB, File does not meet accessibility standards Date: 18. November 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 30413/22

Urgent Field Safety Notice for Ethanol Standard FS by DiaSys Diagnostic Systems GmbH PDF, 755KB, File does not meet accessibility standards Date: 18. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 27325/22

Urgent Field Safety Notice for LDL-c direct FS by DiaSys Diagnostic Systems GmbH PDF, 645KB, File does not meet accessibility standards Date: 18. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 17149/22

Urgent Field Safety Notice for NEFA FS by DiaSys Diagnostic Systems GmbH PDF, 742KB, File does not meet accessibility standards Date: 18. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 18756/22

18. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 30538/22

Urgent Field Safety Notice for IMMULITE/IMMULITE 1000/IMMULITE2000/IMMULITE 2000XPi by Siemens Medical Solutions Diagnostics PDF, 143KB, File does not meet accessibility standards Date: 18. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 09636/19

Urgent Field Safety Notice for Medidrug Ethanol W by MEDICHEM Diagnostica GmbH & Co KG PDF, 1MB, File does not meet accessibility standards Date: 18. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 28249/22

Urgent Field Safety Notice for XQ-Series Automated Hematology Analyzer by Sysmex Japan Corporation PDF, 313KB, File does not meet accessibility standards Date: 18. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – haematological, histological and cytological products
Reference 29430/22

Urgent Field Safety Notice for CLINITEK Novus PRO 12 Urinalysis Cassette by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 198KB, File does not meet accessibility standards Date: 17. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 25027/22

Urgent Field Safety Notice for Alinity hq Analyzer and Alinity hs Slide Maker Stainer Module by Abbott International RA Vigilance Team PDF, 136KB, File does not meet accessibility standards Date: 17. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – haematological, histological and cytological products
Reference 24030/22

Urgent Field Safety Notice for Calprotectin by DRG Instruments GmbH PDF, 831KB, File does not meet accessibility standards Date: 17. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 26480/22

Urgent Field Safety Notice for Columbia-Cap Selektivnährboden + Schafblut PB5082A by Oxoid Deutschland GmbH PDF, 561KB, File does not meet accessibility standards Date: 17. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – microbiological products
Reference 25312/22

Urgent Field Safety Notice for Functional Fibrinogen Kit by Haemonetics Corporation US PDF, 184KB, File does not meet accessibility standards Date: 17. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – haematological, histological and cytological products
Reference 10715/22

Urgent Field Safety Notice for HF-resection electrode, HF cable by Olympus Winter & Ibe GmbH PDF, 2MB, File does not meet accessibility standards Date: 17. November 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrotherapy
Reference 29004/22

17. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – instruments, apparatuses and systems
Reference 15830/22

Urgent Field Safety Notice for Knopfkanüle, Button Cannula, Button (A), 1.2mm by Drescon Surgical PDF, 691KB, File does not meet accessibility standards Date: 17. November 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – syringes and cannulas
Reference 27857/22

Urgent Field Safety Notice for TEG 6s Hemostasis System by HAEMONETICS SA PDF, 1MB, File does not meet accessibility standards Date: 17. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – haematological, histological and cytological products
Reference 17630/22

Urgent Field Safety Notice for Hepcidin 25 (bioactive) HS ELISA by DRG Instruments GmbH PDF, 939KB, File does not meet accessibility standards Date: 17. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 20140/22

Urgent Field Safety Notice for Custom Pak inkl. 3M Steri-Drape Surgical Drapes by Alcon Pharma GmbH PDF, 131KB, File does not meet accessibility standards Date: 17. November 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 29566/22

Urgent Field Safety Notice for Hyalubrix by Fidia Farmaceutici S.p.A. PDF, 70KB, File does not meet accessibility standards Date: 16. November 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – materials for implants
Reference 28628/22

Urgent Field Safety Notice for Iso-Gard® Filter S with Expandi-Flex/Elbow, Tethered Cap; Iso-Gard® Filter S. Iso-Gard® Filter S with Expandi-FlexIso-Gard® Filter S. Tethered Cap; Iso-Gard® Filter S with Expandi-Flex, Tethered Cap; Filter + Catheter Mount by Teleflex (Perak West Malaysia) PDF, 966KB, File does not meet accessibility standards Date: 15. November 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 22511/22

Urgent Field Safety Notice for Cathejell Lidocain C by Pharmazeutische Fabrik Montavit GmbH PDF, 488KB, File does not meet accessibility standards Date: 15. November 2022 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – endoscopes
Reference 29421/22

Urgent Field Safety Notice for DracoFoam (Infekt haft oder haft sensitiv) by Dr. Ausbüttel & Co. GmbH PDF, 279KB, File does not meet accessibility standards Date: 14. November 2022 Topics: Medical devices Type: Customer information

Product group Dressings / Pads – dressings
Reference 29562/22

Urgent Field Safety Notice for ED-FLOW, ED-FLOW S. by Getinge Disinfection AB PDF, 667KB, File does not meet accessibility standards Date: 14. November 2022 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – cleaning / disinfection / sterilisation
Reference 28993/22

11. November 2022 Topics: Medical devices Type: Customer information

Product group Physical therapy – others
Reference 30238/22

Urgent Field Safety Notice for G7 Acetabular System / Ringloc Acetabular Liners by Biomet UK Ltd PDF, 753KB, File does not meet accessibility standards Date: 10. November 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 25917/22

Urgent Field Safety Notice for Endo-Modell Schlitten – Tibiaplateau mit Metallunterlage, außer 7mm by Waldemar Link GmbH & Co. KG PDF, 1MB, File does not meet accessibility standards Date: 10. November 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 28516/22

Urgent Field Safety Notice for DISP.UNIV-SEALING UNIT F/10/12MM TROCARS by Aesculap AG PDF, 3MB, File does not meet accessibility standards Date: 10. November 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – visceral surgery
Reference 28970/22

Urgent Field Safety Notice for Fungitell S.A. by Associates of Cape Co., Inc. PDF, 843KB, File does not meet accessibility standards Date: 10. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – microbiological products
Reference 21051/22

Urgent Field Safety Notice for NEO-fit Neonatal Endotracheal Tube Grip by CooperSurgical, Inc. Trumbull PDF, 520KB, File does not meet accessibility standards Date: 09. November 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 28312/22

Urgent Field Safety Notice for ED-FLOW, ED-FLOW S. by Getinge Disinfection AB PDF, 643KB, File does not meet accessibility standards Date: 09. November 2022 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – cleaning / disinfection / sterilisation
Reference 29002/22

Urgent Field Safety Notice for Ventana PD-L1 by Ventana Medical Systems, Inc PDF, 451KB, File does not meet accessibility standards Date: 09. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 29857/22

Urgent Field Safety Notice for AlproCleaner by Alpro Medical GmbH PDF, 662KB, File does not meet accessibility standards Date: 08. November 2022 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – cleaning / disinfection / sterilisation
Reference 28869/22

Urgent Field Safety Notice for IMMULITE and IMMULITE 1000 Total Testosterone Assay by Siemens Healthcare Diagnostics Products Ltd. PDF, 281KB, File does not meet accessibility standards Date: 08. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 29740/22

07. November 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 28106/22

Urgent Field Safety Notice for EVOLUTION Tibial Base by MicroPort Orthopedics Inc. PDF, 398KB, File does not meet accessibility standards Date: 07. November 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 29077/22

Urgent Field Safety Notice for 3M Steri-Drape Surgical Drapes by 3M Company PDF, 474KB, File does not meet accessibility standards Date: 07. November 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 27692/22

Urgent Field Safety Notice for Freelite Human Lambda Free kit for use on the Siemens BN ProSpec by The Binding Site Group Limited PDF, 269KB, File does not meet accessibility standards Date: 07. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 29018/22

Urgent Field Safety Notice for RM Pfannensetzinstrument gerade/kurviert by Mathys AG Bettlach PDF, 617KB, File does not meet accessibility standards Date: 07. November 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – bone surgery
Reference 28387/22

Urgent Field Safety Notice for Vliwaktiv Absorbent Activated Charcoal Dressing by Lohmann und Rauscher GmbH & Co. KG PDF, 106KB, File does not meet accessibility standards Date: 07. November 2022 Topics: Medical devices Type: Customer information

Product group Dressings / Pads – dressings
Reference 29563/22

Urgent Field Safety Notice for Ambix Nova by Fresenius Kabi AG PDF, 106KB, File does not meet accessibility standards Date: 07. November 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 28378/22

Urgent Field Safety Notice for BD Connecta by Becton Dickinson Infusion Therapy AB PDF, 516KB, File does not meet accessibility standards Date: 07. November 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion kits
Reference 29385/22

Urgent Field Safety Notice for Patient set for Aqua-vision by Hemodia PDF, 726KB, File does not meet accessibility standards Date: 04. November 2022 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – endoscopes
Reference 29020/22

Urgent Field Safety Notice for A-CP Kits Family, RegenKit-BCT Family by Regen Lab SA PDF, 3MB, File does not meet accessibility standards Date: 03. November 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – equipment for collecting blood products and peripheral stem cells
Reference 21240/22

03. November 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology – radiological equipment for vascular diagnostics
Reference 27023/22

Urgent Field Safety Notice for Omnipod DASH Insulin Management System by Insulet Corporation London PDF, 248KB, File does not meet accessibility standards Date: 02. November 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 27449/22

Urgent Field Safety Notice for Hill-Rom900, CenturisPro and Ampera by Hill-Rom SAS PDF, 1MB, File does not meet accessibility standards Date: 31. October 2022 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – furnishings
Reference 28148/22

Urgent Field Safety Notice for ThermoCool SmartTouch Catheter by Biosense Webster, Inc. (Diamond Bar) PDF, 1MB, File does not meet accessibility standards Date: 31. October 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 23353/22

Urgent Field Safety Notice for Hyalubrix by Fidia Farmaceutici S.p.A. PDF, 168KB, File does not meet accessibility standards Date: 31. October 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – materials for implants
Reference 27014/22

Urgent Field Safety Notice for VS3 Iridium- MMS-IR and Beam-Combiner by Visionsense Ltd. PDF, 1MB, File does not meet accessibility standards Date: 28. October 2022 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – endoscopes
Reference 28242/22

Urgent Field Safety Notice for HeartWare Ventricular Assist System by Heartware, Inc. PDF, 164KB, File does not meet accessibility standards Date: 28. October 2022 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – artificial hearts
Reference 21994/20

Urgent Field Safety Notice for sphingotest DPP3 by SphingoTec GmbH PDF, 565KB, File does not meet accessibility standards Date: 28. October 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 27694/22

Urgent Field Safety Notice for TDT (EP266) by VITRO S.A PDF, 782KB, File does not meet accessibility standards Date: 28. October 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 28758/22

Urgent Field Safety Notice for Sonicaid Freedom by Huntleigh Healthcare Ltd. Diagnostics PDF, 1MB, File does not meet accessibility standards Date: 28. October 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 28358/22

27. October 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 27739/22

Urgent Field Safety Notice for WiSE CRT Transmitter by EBR Systems, INC PDF, 320KB, File does not meet accessibility standards Date: 27. October 2022 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – cardiac pacemakers
Reference 28273/22

Urgent Field Safety Notice for TRACOE vario P, TRACOE experc Set vario, TRACOE twist plus P, TRACOE experc Set twist plus by TRACOE medical GmbH Nieder-Olm PDF, 954KB, File does not meet accessibility standards Date: 26. October 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 28229/22

Urgent Field Safety Notice for Humidifier Bottle and Syringe filter kit for BT37 by Planer Limited PDF, 379KB, File does not meet accessibility standards Date: 21. October 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 20641/22

Urgent Field Safety Notice for Elm dosing pipette by Elm Plastic GmbH PDF, 1MB, File does not meet accessibility standards Date: 19. October 2022 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – dosing systems
Reference 20306/22

Urgent Field Safety Notice for Tissue Storage Plate (Warm Plate, Vitri Plate) by REPROLIFE PDF, 253KB, File does not meet accessibility standards Date: 19. October 2022 Topics: Medical devices Type: Customer information

Product group In vitro fertilization – others
Reference 26878/22

Urgent Field Safety Notice for ORISE Gel Submucosal Lifting Agent by Boston Scientific Corporation Marlborough PDF, 282KB, File does not meet accessibility standards Date: 18. October 2022 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – endoscopes
Reference 27298/22

Urgent Field Safety Notice for Starling Monitor, Starling Monitor with SPO2 by Cheetah Medical (Israel) Ltd. PDF, 65KB, File does not meet accessibility standards Date: 14. October 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 23998/22

Urgent Field Safety Notice for i.s.h.med by Cerner Corporation PDF, 94KB, File does not meet accessibility standards Date: 14. October 2022 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 15909/22

Urgent Field Safety Notice for Custom procedure trays containing Gelita Tampon by ArcRoyal Ltd. PDF, 205KB, File does not meet accessibility standards Date: 14. October 2022 Topics: Medical devices Type: Customer information

Product group Dressings / Pads – ointments and gels
Reference 27715/22

14. October 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 27608/22

Urgent Field Safety Notice for EMBLEM S-ICD and EMBLEM MRI S-ICD by Boston Scientific CRM PDF, 157KB, File does not meet accessibility standards Date: 14. October 2022 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – defibrillators
Reference 26542/22

Urgent Field Safety Notice for LeMaitre Single Lumen Embolectomy Catheter by LeMaitre Vascular (vormals Endomed Inc.) PDF, 388KB, File does not meet accessibility standards Date: 13. October 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 27079/22

Urgent Field Safety Notice for Infusion set with backcheck valve by Shandong Lee Med Technology Co., Ltd. PDF, 406KB, File does not meet accessibility standards Date: 13. October 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 23755/22

Urgent Field Safety Notice for Generator, E-100 by Intuitive Surgical SAS PDF, 209KB, File does not meet accessibility standards Date: 12. October 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 17486/22

Urgent Field Safety Notice for V-LOC by Covidien llc PDF, 334KB, File does not meet accessibility standards Date: 12. October 2022 Topics: Medical devices Type: Customer information

Product group Dressings / Pads – surgical sutures, vascular loops etc.
Reference 25933/22

Urgent Field Safety Notice for LOWTeq pdms by LOWTeq GmbH PDF, 661KB, File does not meet accessibility standards Date: 12. October 2022 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 16024/22

Urgent Field Safety Notice for CamAPS FX software by CamDiab Ltd PDF, 96KB, File does not meet accessibility standards Date: 11. October 2022 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – medical apps
Reference 26874/22

Urgent Field Safety Notice for FARAWAVE – FARASTAR – FARAPULSE SYSTEM by Farapulse, Inc. PDF, 171KB, File does not meet accessibility standards Date: 11. October 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 24499/22

Urgent Field Safety Notice for DBLG1 / DBLHU by DIABELOOP PDF, 148KB, File does not meet accessibility standards Date: 11. October 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electric blood glucose meters
Reference 25787/22

10. October 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 26253/22

Urgent Field Safety Notice for GELITA-TAMPON by B. Braun Surgical S.A. PDF, 743KB, File does not meet accessibility standards Date: 10. October 2022 Topics: Medical devices Type: Customer information

Product group Dressings / Pads – dressings
Reference 26602/22

Urgent Field Safety Notice for Beach Chair, Lithotomy, Spine Positioner, Table by Baxter International, Hill-Rom, Allen Medical PDF, 125KB, File does not meet accessibility standards Date: 10. October 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 24178/22

Urgent Field Safety Notice for Pinnacle Radiation Therapy Planning System by Philips Medical Systems (Cleveland), Inc. Gainesville PDF, 1MB, File does not meet accessibility standards Date: 07. October 2022 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection – radiotherapy treatment planning systems
Reference 21969/22

Urgent Field Safety Notice for AUTOPULSE LI-ION BATTERY by ZOLL USA PDF, 296KB, File does not meet accessibility standards Date: 07. October 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrotherapy
Reference 26153/22

Urgent Field Safety Notice for Valon TT (TT532 and TT 577) by Meridian Medical Oy PDF, 208KB, File does not meet accessibility standards Date: 07. October 2022 Topics: Medical devices Type: Customer information

Product group ophthalmological technology – equipment for ophthalmological therapeutics
Reference 17018/22

Urgent Field Safety Notice for SUSI EVES TONSIL SNARE / SUSI TONSILLENSCHNÜRER EVES by Aesculap AG PDF, 2MB, File does not meet accessibility standards Date: 05. October 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – general instruments
Reference 25550/22

Urgent Field Safety Notice for Fogarty Arterial Embolectomy Catheters, Fogarty Fortis Arterial Embolectomy Catheters, Fogarty Biliary Balloon Probes by Edwards Lifesciences LLC PDF, 313KB, File does not meet accessibility standards Date: 05. October 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 25830/22

Urgent Field Safety Notice for GXL Liners for Novation, Acumatch and MCS systems by EXACTECH, Inc. PDF, 6MB, File does not meet accessibility standards Date: 04. October 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 18832/21