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Urgent Field Safety Notice for Big Easy Insert, NEXTEMP CEMENT STANDARD, PREMIER TOTAL ETCH GEL by Premier Dental Products Co., Inc. PDF, 8MB, File does not meet accessibility standards Date: 02. December 2019 Topics: Medical devices Type: Customer information

Product group Dental products - instruments
Reference 16220/19

Urgent Field Safety Notice for Cardiaid, AED Electrodes by Cardia International A/S PDF, 533KB, File does not meet accessibility standards Date: 02. December 2019 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 11657/19

Urgent Field Safety Notice for Heart Valve Reconstruction System (Mitral and Tricuspid) by Edwards Cardioband PDF, 3MB, File does not meet accessibility standards Date: 02. December 2019 Topics: Medical devices Type: Customer information

Product group Non-active implants - cardiac surgery
Reference 15466/19

Urgent Field Safety Notice for OLYMPUS DUODENOVIDEOSCOPES & DUODENOFIBERSCOPES by Olympus Medical Systems Corp. PDF, 450KB, File does not meet accessibility standards Date: 28. November 2019 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 15494/19

Urgent Field Safety Notice for RayStation by RaySearch Laboratories AB PDF, 54KB, File does not meet accessibility standards Date: 27. November 2019 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 16085/19

Urgent Field Safety Notice for Cios Alpha by Siemens Healthcare GmbH, X-Ray Products (XP) PDF, 858KB, File does not meet accessibility standards Date: 27. November 2019 Topics: Medical devices Type: Customer information

Product group Radiological technology - mobile radiological diagnostic facilities
Reference 15985/19

Urgent Field Safety Notice for Romed I.V. Catheter With lnjection Port by Van Oostveen Medical B.V., Wilnis, NL PDF, 65KB, File does not meet accessibility standards Date: 27. November 2019 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 16071/19

Urgent Field Safety Notice for CapsoCam Plus (SV-3) by CapsoVision, Inc PDF, 106KB, File does not meet accessibility standards Date: 26. November 2019 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 15342/19

Urgent Field Safety Notice for BIOSOFT Duo Set und VORTEK Set by Coloplast A/S PDF, 100KB, File does not meet accessibility standards Date: 26. November 2019 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 15241/19

Urgent Field Safety Notice for Python®, BARD Latex-free, Over-the-Wire latis® by Applied Medical Resources PDF, 255KB, File does not meet accessibility standards Date: 26. November 2019 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 15942/19

Urgent Field Safety Notice for TruCal CRP by DiaSys Diagnostic Systems GmbH PDF, 2MB, File does not meet accessibility standards Date: 25. November 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 15506/19

Urgent Field Safety Notice for Aespire 7100, Aestiva 7900/MRI/7100/100 by Datex-Ohmeda, Inc. PDF, 205KB, File does not meet accessibility standards Date: 22. November 2019 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 09207/19

Urgent Field Safety Notice for Monaco RTP System by IMPAC Medical Systems, Inc. PDF, 74KB, File does not meet accessibility standards Date: 22. November 2019 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 15855/19

Urgent Field Safety Notice for GORE DrySeal Flex Introducer Sheath by W.L. Gore & Associates, Inc. PDF, 633KB, File does not meet accessibility standards Date: 22. November 2019 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 15709/19

Urgent Field Safety Notice for CARESCAPE-Beatmungsmodule E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE by GE Healthcare Finland Oy PDF, 364KB, File does not meet accessibility standards Date: 22. November 2019 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 15873/19

Urgent Field Safety Notice for PneumoDart by TyTek Medical Inc. PDF, 101KB, File does not meet accessibility standards Date: 22. November 2019 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Reference 15865/19

Urgent Field Safety Notice for Giraffe Omnibed and Giraffe Incubator; Giraffe Warmer, Panda i.e. Warmer by Datex-Ohmeda, Inc PDF, 407KB, File does not meet accessibility standards Date: 21. November 2019 Topics: Medical devices Type: Customer information

Product group Physical therapy - climatotherapy
Reference 11549/19

Urgent Field Safety Notice for CHA Anesthesia and CHA Critical Care by GE Healthcare PDF, 203KB, File does not meet accessibility standards Date: 21. November 2019 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 12258/19

Urgent Field Safety Notice for Luftkalorisator / Air Calorisator by Homoth Medizinelektronik GmbH & Co.KG PDF, 962KB, File does not meet accessibility standards Date: 21. November 2019 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - ENT equipment
Reference 15529/19

Urgent Field Safety Notice for CHA Anesthesia and CHA Critical Care by GE Healthcare PDF, 272KB, File does not meet accessibility standards Date: 21. November 2019 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 15495/19

Urgent Field Safety Notice for MediEject II by GCE s.r.o. PDF, 3MB, File does not meet accessibility standards Date: 21. November 2019 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - drainages and suction systems
Reference 15214/19

Urgent Field Safety Notice for MEDUCORE Standard 2 by WEINMANN Emergency Medical Technology GmbH + Co. KG PDF, 46KB, File does not meet accessibility standards Date: 20. November 2019 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 15583/19

Urgent Field Safety Notice for Syramed µSP6000 by Arcomed AG PDF, 112KB, File does not meet accessibility standards Date: 20. November 2019 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 00046/18

Urgent Field Safety Notice for PRECISE, S.M.A.R.T., S.M.A.R.T. Control by Cordis Corporation PDF, 218KB, File does not meet accessibility standards Date: 19. November 2019 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 15431/19

Urgent Field Safety Notice for Prometra Programmable Pump by Flowonix Medical PDF, 5MB, File does not meet accessibility standards Date: 19. November 2019 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - drug pumps
Reference 15524/19

Urgent Field Safety Notice for Taylor Dura Schere, Cushing Dura Haken, Frazier Du by Ortho Select GmbH PDF, 101KB, File does not meet accessibility standards Date: 18. November 2019 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - neurosurgery
Reference 15512/19

Urgent Field Safety Notice for Artis zee by Siemens Healthcare GmbH, X-Ray Products (XP) PDF, 730KB, File does not meet accessibility standards Date: 15. November 2019 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 15350/19

Urgent Field Safety Notice for AngioJet Ultra 5000A Console Foot Switch by Boston Scientific Corporation Marlborough PDF, 820KB, File does not meet accessibility standards Date: 15. November 2019 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 15249/19

Urgent Field Safety Notice for Combihesive Natura, konvexe Basisplatte by ConvaTec PDF, 1MB, File does not meet accessibility standards Date: 15. November 2019 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - care of natural and artificial body orifices
Reference 12651/19

Urgent Field Safety Notice for PASCAL Transcatheter Mitral Valve Repair System by Edwards Lifesciences LLC PDF, 190KB, File does not meet accessibility standards Date: 14. November 2019 Topics: Medical devices Type: Customer information

Product group Non-active implants - cardiac surgery
Reference 15289/19