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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

Urgent Field Safety Notice for Vectris by Medtronic Inc PDF, 73KB, File does not meet accessibility standards Date: 16. January 2019 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - biostimulators
Reference 08795/18

Urgent Field Safety Notice for Artikon.genu-bi-lock Systemkniegelenksatz mit Sperre, Systemschienenbreite 16 und 20 mm by Streifeneder ortho.production GmbH PDF, 354KB, File does not meet accessibility standards Date: 16. January 2019 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - orthoses
Reference 00530/19

Urgent Field Safety Notice for Reverse Loaded Wire Guides by Cook Incorporated PDF, 91KB, File does not meet accessibility standards Date: 16. January 2019 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 00517/19

Urgent Field Safety Notice for Intera, Enterprise, Achieva, Achieva XT, Achieva C by Philips Medical Systems Nederland B.V. PDF, 444KB, File does not meet accessibility standards Date: 14. January 2019 Topics: Medical devices Type: Customer information

Product group Electromedical fields - equipment for MR tomography
Reference 00410/19

Urgent Field Safety Notice for Senographe Crystal Nova by GE ULTRASOUND KOREA, LTD PDF, 382KB, File does not meet accessibility standards Date: 14. January 2019 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for mammographic diagnostics
Reference 00401/19

Urgent Field Safety Notice for HeartStart MRx by Philips Healthcare PDF, 1,023KB, File does not meet accessibility standards Date: 14. January 2019 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 15004/18

Urgent Field Safety Notice for Reprocessed Biosense Webster Lasso 2515 NAV eco Va by Stryker Sustainability Solutions PDF, 143KB, File does not meet accessibility standards Date: 14. January 2019 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 15794/18

Urgent Field Safety Notice for PLUS S. MIA DBL OFFSET ADAPT. RT 60/25MM by Smith & Nephew Orthopaedics AG PDF, 115KB, File does not meet accessibility standards Date: 11. January 2019 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 00244/19

Urgent Field Safety Notice for Accu-Chek Insight by Roche Diabetes Care GmbH PDF, 106KB, File does not meet accessibility standards Date: 11. January 2019 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 14873/18

Urgent Field Safety Notice for smartPen, 2 Tasten, ø2,4mm, 4 by Gebrüder Martin GmbH & Co. KG PDF, 226KB, File does not meet accessibility standards Date: 11. January 2019 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 15755/18

Urgent Field Safety Notice for UNIMED Medical Needle by UNIMED S.A. PDF, 59KB, File does not meet accessibility standards Date: 11. January 2019 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - injection kits
Reference 00265/19

Urgent Field Safety Notice for CLEAN by Roche Diagnostics GmbH PDF, 488KB, File does not meet accessibility standards Date: 10. January 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 15187/18

Urgent Field Safety Notice for Dimension Vista 500/1500 mit Progard Vorbehandlungspack by Siemens Healthcare Diagnostics Inc. Newark PDF, 100KB, File does not meet accessibility standards Date: 10. January 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 16169/18

Urgent Field Safety Notice for BILT3,IGM-2, LACT2 und Lactate by Roche Diagnostics GmbH PDF, 171KB, File does not meet accessibility standards Date: 10. January 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 15042/18

Urgent Field Safety Notice for cobas 8100 system- see below in "Accessories" by Hitachi High Technologies Corporation (HHT), Medical Systems QA Group PDF, 544KB, File does not meet accessibility standards Date: 10. January 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 15505/18

Urgent Field Safety Notice for Fructosamine Calibrators and Controls by Randox Laboratories Ltd PDF, 682KB, File does not meet accessibility standards Date: 10. January 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 15188/18

Urgent Field Safety Notice for cobas t 511 and t 711 - Coagulation analyzer by Roche Diagnostics GmbH PDF, 480KB, File does not meet accessibility standards Date: 10. January 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 15685/18

Urgent Field Safety Notice for Various by Abbott Ireland Diagnostics Division PDF, 183KB, File does not meet accessibility standards Date: 10. January 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 14662/18

Urgent Field Safety Notice for Alinity i Processing Module by Abbott GmbH & Co. KG PDF, 128KB, File does not meet accessibility standards Date: 10. January 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 16124/18

Urgent Field Safety Notice for VITROS Chemistry Products VALP Slides by Ortho-Clinical Diagnostics, Inc. PDF, 367KB, File does not meet accessibility standards Date: 10. January 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 15681/18

Urgent Field Safety Notice for Quo-Test A1C Test Kit by EKF-diagnostic GmbH PDF, 3MB, File does not meet accessibility standards Date: 10. January 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 15923/18