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Urgent Field Safety Notice for Immunoassay-Systeme UniCel DxI 600 und 800 Access by Beckman Coulter, Inc. PDF, 136KB, File does not meet accessibility standards Date: 31. January 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 15851/18

Urgent Field Safety Notice for T-Cell Select by Oxford Immunotec Ltd. PDF, 332KB, File does not meet accessibility standards Date: 31. January 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 00425/19

Urgent Field Safety Notice for Direct Radiography system DX-D 600 by Agfa HealthCare N.V. PDF, 121KB, File does not meet accessibility standards Date: 30. January 2019 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 14850/18

Urgent Field Safety Notice for Breathing Circuits/Anesthesia Sets/Pack2Go/Set2Go by Drägerwerk AG & Co. KGaA PDF, 2MB, File does not meet accessibility standards Date: 30. January 2019 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 15984/18

Urgent Field Safety Notice for Philips Hemodynamic Application R1.0 by Philips Medical Systems Nederland B.V. PDF, 242KB, File does not meet accessibility standards Date: 30. January 2019 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 16137/18

Urgent Field Safety Notice for MAKO Vizadisc Knee/Hip Procedure Tracking Kit by MAKO Surgical Corp. PDF, 152KB, File does not meet accessibility standards Date: 29. January 2019 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 09591/18

Urgent Field Safety Notice for Agile Biliary RX Fully Covered Stent System by Boston Scientific Corporation Marlborough PDF, 162KB, File does not meet accessibility standards Date: 29. January 2019 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 00977/19

Urgent Field Safety Notice for Fitbone TAA by Wittenstein intens GmbH PDF, 70KB, File does not meet accessibility standards Date: 29. January 2019 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - others
Reference 00643/19

Urgent Field Safety Notice for Harmonic ACE Curved Shears Insert by Intuitive Surgical, Inc. PDF, 613KB, File does not meet accessibility standards Date: 29. January 2019 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 00005/19

Urgent Field Safety Notice for Xper Flex Cardio Physiomonitoring System by Philips Medical Systems PDF, 85KB, File does not meet accessibility standards Date: 29. January 2019 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 00775/19

Urgent Field Safety Notice for Suction Catheters, Gastro-enteral Tubes by ConvaTec Limited Deeside PDF, 484KB, File does not meet accessibility standards Date: 25. January 2019 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 08395/18

Urgent Field Safety Notice for Instrument Tray, Basic T2 Femur Long by Stryker Trauma Kiel PDF, 192KB, File does not meet accessibility standards Date: 24. January 2019 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 00817/19

Urgent Field Safety Notice for Acusnare Polypectomy Snares by Cook Endoscopy PDF, 100KB, File does not meet accessibility standards Date: 24. January 2019 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 16254/18

Urgent Field Safety Notice for CareLink Programmer; CareLink Encore Programmer by Medtronic Inc PDF, 279KB, File does not meet accessibility standards Date: 24. January 2019 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - defibrillators
Reference 00810/19

Urgent Field Safety Notice for Nellix (Version 3.5), Endovascular Aneurysm Sealing System by Endologix, Inc. PDF, 1MB, File does not meet accessibility standards Date: 23. January 2019 Topics: Medical devices Type: Customer information

Product group Non-active implants - other implants
Reference 00100/19

Urgent Field Safety Notice for Absaug-, S.ül- oder Drainageschlauch by Silikon-Technik Siltec GmbH & Co. KG PDF, 2MB, File does not meet accessibility standards Date: 23. January 2019 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 00799/19

Urgent Field Safety Notice for Spectra Optia System by Terumo BCT, Inc PDF, 75KB, File does not meet accessibility standards Date: 23. January 2019 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - therapeutic apheresis procedures
Reference 15377/18

Urgent Field Safety Notice for T34 syringe pump by Caesarea Medical Electronics Ltd. PDF, 2MB, File does not meet accessibility standards Date: 23. January 2019 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 04121/18

Urgent Field Safety Notice for Efficia CM10, CM12, CM100, CM120, CM150 by Philips Medical Systems PDF, 151KB, File does not meet accessibility standards Date: 23. January 2019 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 00770/19

Urgent Field Safety Notice for Intraclude device by Edwards Lifesciences Utah PDF, 661KB, File does not meet accessibility standards Date: 23. January 2019 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 00778/19

Urgent Field Safety Notice for Trima Accel System (Automated Blood Collection) by Terumo BCT, Inc PDF, 92KB, File does not meet accessibility standards Date: 23. January 2019 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - equipment for collecting blood products and peripheral stem cells
Reference 15373/18

Urgent Field Safety Notice for Celsite Implantofix by B.BRAUN MEDICAL PDF, 30KB, File does not meet accessibility standards Date: 22. January 2019 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 00756/19

Urgent Field Safety Notice for NIM-ECLIPSE System by Medtronic Xomed Inc. PDF, 68KB, File does not meet accessibility standards Date: 22. January 2019 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 12523/17

Urgent Field Safety Notice for Ingenuity TF PET/CT by PHILIPS MEDICAL SYSTEMS (Cleveland), Inc. (CL) PDF, 3MB, File does not meet accessibility standards Date: 22. January 2019 Topics: Medical devices Type: Customer information

Product group Radiological technology - CT scanners
Reference 00051/18

Urgent Field Safety Notice for Ziehm Vision RFD; Vision RFD 3D; Ziehm Solo FD by Ziehm Imaging GmbH PDF, 26KB, File does not meet accessibility standards Date: 22. January 2019 Topics: Medical devices Type: Customer information

Product group Radiological technology - mobile radiological diagnostic facilities
Reference 00399/19

Urgent Field Safety Notice for Burr, Oval, 12 Flute, 5.5 mm x 13 cm by Arthrex INC PDF, 86KB, File does not meet accessibility standards Date: 22. January 2019 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 00649/19

Urgent Field Safety Notice for ECLIPSE 2L by BALT Extrusion PDF, 312KB, File does not meet accessibility standards Date: 18. January 2019 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 00284/19

Urgent Field Safety Notice for Percuvance 29cm Shaft Percuvance 36cm Shaft by Teleflex Medical USA PDF, 185KB, File does not meet accessibility standards Date: 17. January 2019 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 00553/19

Urgent Field Safety Notice for Leica M220 F12 by Leica Microsystems (Schweiz) AG PDF, 1MB, File does not meet accessibility standards Date: 17. January 2019 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - medical microscopes (does not incude laboratory microscopes)
Reference 15768/18

Urgent Field Safety Notice for Lambotte-Meißel, 20mm by aap Implantate AG PDF, 4MB, File does not meet accessibility standards Date: 16. January 2019 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 15997A/18