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Urgent Field Safety Notice for C-RAD Gating Box HZ-009. c4D Software by C-RAD Positioning AB PDF, 10MB, File does not meet accessibility standards Date: 06. December 2019 Topics: Medical devices Type: Customer information

Product group Radiological technology - navigation systems
Reference 16364/19

Urgent Field Safety Notice for QuickDraw Venous Cannula by Edwards Lifesciences LLC PDF, 182KB, File does not meet accessibility standards Date: 06. December 2019 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 16401/19

Urgent Field Safety Notice for Dexcom G6 CGM System by Dexcom, Inc. PDF, 603KB, File does not meet accessibility standards Date: 06. December 2019 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electric blood glucose meters
Reference 16035/19

Urgent Field Safety Notice for lic2 (low impadance cream) by SOMNOmedics GmbH PDF, 1MB, File does not meet accessibility standards Date: 05. December 2019 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - ointments and gels
Reference 16404/19

Urgent Field Safety Notice for Skalpellklinge, Fig 15 steril by Gebrüder Martin GmbH & Co. KG PDF, 4MB, File does not meet accessibility standards Date: 04. December 2019 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - general instruments
Reference 16326/19

Urgent Field Safety Notice for BritePro Solo Single Use Fibre Optic Laryngoscope by Flexicare Medical Limited PDF, 2MB, File does not meet accessibility standards Date: 04. December 2019 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - medical microscopes (does not incude laboratory microscopes)
Reference 13604/19

Urgent Field Safety Notice for Mitek HEALIX ADVANCE, HEALIX ADVANCE Knotless, MILAGRO ADVANCE, and INTRAFIX Advance by DePuySynthes Mitek Sports Medicine PDF, 271KB, File does not meet accessibility standards Date: 03. December 2019 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 15306/19

Urgent Field Safety Notice for TI POLYAXIAL HEAD FOR USS POLYAXIAL; TI COLLAR FOR 6.0MM RODS FOR USS POLYAXIAL by Synthes GmbH PDF, 82KB, File does not meet accessibility standards Date: 03. December 2019 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 15446/19

Urgent Field Safety Notice for Durapore Advanced Surgical Tape by 3M Deutschland GmbH PDF, 43KB, File does not meet accessibility standards Date: 03. December 2019 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - bandages
Reference 16299/19

Urgent Field Safety Notice for Detachable Azur Peripheral Coil System by MicroVention, Inc PDF, 3MB, File does not meet accessibility standards Date: 03. December 2019 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 16319/19

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