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Urgent Field Safety Notice for NF-light ELISA by UmanDiagnostics AB PDF, 196KB, File does not meet accessibility standards Date: 22. March 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 04210/21

Urgent Field Safety Notice for Relay Plus and Relay 85 by Bolton Medical lnc. PDF, 204KB, File does not meet accessibility standards Date: 22. March 2021 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 03738/21

Urgent Field Safety Notice for POCKIT Central Nucleic Acid Analyzer by GeneReach Biotechnology Corp. PDF, 200KB, File does not meet accessibility standards Date: 22. March 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 00117/21

Urgent Field Safety Notice for SARS-CoV-2 antigen IVD, kit, fluorescent immunoass by LumiraDx UK Ltd PDF, 448KB, File does not meet accessibility standards Date: 22. March 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 03643/21

Urgent Field Safety Notice for Arrow OnControl Bone Lesion Biopsy System Tray by Teleflex Medical Athlone PDF, 197KB, File does not meet accessibility standards Date: 19. March 2021 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - general instruments
Reference 04719/21

Urgent Field Safety Notice for HeartStart FR2/FR2+ by Philips Healthcare, Bothell PDF, 197KB, File does not meet accessibility standards Date: 19. March 2021 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 04679/21

Urgent Field Safety Notice for ENROUTE Transcarotid Stent System by Silk Road Medical, Inc. PDF, 462KB, File does not meet accessibility standards Date: 19. March 2021 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 04463/21

Urgent Field Safety Notice for RetCam Envision Lens by Natus Medical Incorporated - Ontario PDF, 142KB, File does not meet accessibility standards Date: 19. March 2021 Topics: Medical devices Type: Customer information

Product group ophthalmological technology - equipment for ophthalmological diagnostics
Reference 04332/21

Urgent Field Safety Notice for Extreme H20 59 Xtra by Clerio Vision PDF, 131KB, File does not meet accessibility standards Date: 19. March 2021 Topics: Medical devices Type: Customer information

Product group ophthalmological technology - contact lenses
Reference 05001/21

Urgent Field Safety Notice for Spiros by ICU Medical Inc. PDF, 210KB, File does not meet accessibility standards Date: 17. March 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 04989/21

Urgent Field Safety Notice for MBT Cemented Keel Tibial Base 2 and ATTUNE FB AND RP by DePuy Ireland Ltd PDF, 274KB, File does not meet accessibility standards Date: 15. March 2021 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 04092/21

Urgent Field Safety Notice for WiSE CRT Transmitter by EBR Systems, INC PDF, 257KB, File does not meet accessibility standards Date: 12. March 2021 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - cardiac pacemakers
Reference 04252/21

Urgent Field Safety Notice for Univation X Kneesystem by Aesculap AG PDF, 3MB, File does not meet accessibility standards Date: 12. March 2021 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 04199/21

Urgent Field Safety Notice for AMPLATZER TorqVue LP Delivery System by Abbott Plymouth, Product Performance Group PDF, 71KB, File does not meet accessibility standards Date: 10. March 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 04550/21

Urgent Field Safety Notice for Amicus MNC-Apherese-Set by Fresenius Kabi Deutschland GmbH PDF, 111KB, File does not meet accessibility standards Date: 10. March 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - equipment for collecting blood products and peripheral stem cells
Reference 03456/21

Urgent Field Safety Notice for M.Scio by Christoph Miethke GmbH & Co. KG PDF, 478KB, File does not meet accessibility standards Date: 09. March 2021 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - others
Reference 04304/21

Urgent Field Safety Notice for Fenom Pro Asthma Monitor by Caire Diagnostics PDF, 83KB, File does not meet accessibility standards Date: 09. March 2021 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - pulmonary function diagnostics
Reference 04456/21

Urgent Field Safety Notice for Sensis, Sensis Vibe Combo, Sensis Vibe Hemo by Siemens Healthcare GmbH, Advanced Therapies Angiographie PDF, 152KB, File does not meet accessibility standards Date: 09. March 2021 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 04045/21

Urgent Field Safety Notice for FRED easyport plus by Schiller AG PDF, 10MB, File does not meet accessibility standards Date: 09. March 2021 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 04247/21

Urgent Field Safety Notice for CyberKnife Robotic Radiosurgery System by Accuray Incorporated PDF, 4MB, File does not meet accessibility standards Date: 09. March 2021 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 04531/21