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Urgent Field Safety Notice for Diverse Dentalimplantate by VICTORY PDF, 545KB, File does not meet accessibility standards Date: 20. September 2018 Topics: Medical devices Type: Customer information

Product group Dental products - dental implants
Reference 05381/18

Urgent Field Safety Notice for Peek Acuity Pro by Peek Vision Ltd PDF, 107KB, File does not meet accessibility standards Date: 20. September 2018 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) - medical apps
Reference 10365/18

Urgent Field Safety Notice for AFX EndoVascular AAA System by Endologix, Inc. PDF, 367KB, File does not meet accessibility standards Date: 20. September 2018 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 11840/18

Urgent Field Safety Notice for Low Volume IV Filter / BC 693 by Bayer Medical Care Inc. PDF, 49KB, File does not meet accessibility standards Date: 20. September 2018 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion kits
Reference 11853/18

Urgent Field Safety Notice for Lone Star Single-Use Elastic Stays by Cooper Surgical Inc. PDF, 199KB, File does not meet accessibility standards Date: 18. September 2018 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - visceral surgery
Reference 11719/18

Urgent Field Safety Notice for CARESCAPE Monitor B650 by GE Healthcare Finland Oy PDF, 540KB, File does not meet accessibility standards Date: 17. September 2018 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 07892/18

Urgent Field Safety Notice for Accelerator a3600 by Inpeco SA PDF, 2MB, File does not meet accessibility standards Date: 17. September 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 10915/18

Urgent Field Safety Notice for FilmArray Blood Culture Identification (BCID) Panel by BioFire Diagnostics, LLC PDF, 171KB, File does not meet accessibility standards Date: 17. September 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 11171/18

Urgent Field Safety Notice for Aptio Automation by Inpeco SA PDF, 1MB, File does not meet accessibility standards Date: 17. September 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 10916/18

Urgent Field Safety Notice for Alere Triage NT-proBNP Test by Alere San Diego, Inc. PDF, 111KB, File does not meet accessibility standards Date: 17. September 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 11122/18

Urgent Field Safety Notice for Alere DDS2 Test Kit by Alere Toxicology Plc PDF, 43KB, File does not meet accessibility standards Date: 17. September 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 11654/18

Urgent Field Safety Notice for ALTRIX, 220-240V/50HZ, TYPE F by Stryker Medical-Kalamazoo PDF, 626KB, File does not meet accessibility standards Date: 17. September 2018 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 11707/18

Urgent Field Safety Notice for LATITUDE Programmer by Boston Scientific CRM PDF, 225KB, File does not meet accessibility standards Date: 13. September 2018 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - cardiac pacemakers
Reference 11544/18

Urgent Field Safety Notice for ACCOLADE, ACCOLADE MRI; PROPONENT, PPOPONENT MRI; ESSENTIO, ESSENTIO MRI; VISIONIST X4; VALITUDE X4 by Boston Scientific CRM PDF, 38KB, File does not meet accessibility standards Date: 13. September 2018 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - cardiac pacemakers
Reference 11557/18

Urgent Field Safety Notice for Neuro Omega by Alpha Omega Engineering Ltd. PDF, 251KB, File does not meet accessibility standards Date: 13. September 2018 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 11377/18

Urgent Field Safety Notice for Cell Observer S., DirectFRAP, Laser TIRF by Carl Zeiss Microscopy GmbH PDF, 127KB, File does not meet accessibility standards Date: 12. September 2018 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - medical microscopes (does not incude laboratory microscopes)
Reference 05567/18

Urgent Field Safety Notice for RePlant Precision IO Scan Adapter by Implant Direct Sybron Manufacturing, LLC. PDF, 205KB, File does not meet accessibility standards Date: 11. September 2018 Topics: Medical devices Type: Customer information

Product group Dental products - dental implants
Reference 11226/18

Urgent Field Safety Notice for Getinge WD15 Claro by Getinge Disinfection AB PDF, 478KB, File does not meet accessibility standards Date: 11. September 2018 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - cleaning / disinfection / sterilisation
Reference 07194/18

Urgent Field Safety Notice for Cannulated tap, 5.5 mm by icotec ag PDF, 2MB, File does not meet accessibility standards Date: 10. September 2018 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 11368/18

Urgent Field Safety Notice for Enzymatic Creatinine OSR6x204, HDL Cholesterol OSR6x87, Lipase OSR6x30 and Uric Acid OSR6x98 by Beckman Coulter Ireland Inc. PDF, 698KB, File does not meet accessibility standards Date: 10. September 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 11230/18

Urgent Field Safety Notice for FLEX Monoclonal Mouse Anti-Human Progesterone Rece by Dako North America, Inc. PDF, 46KB, File does not meet accessibility standards Date: 10. September 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 11223/18

Urgent Field Safety Notice for EEA Circular Stapler with Tri-Staple Technology by Covidien llc PDF, 203KB, File does not meet accessibility standards Date: 10. September 2018 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - general instruments
Reference 10913/18

Urgent Field Safety Notice for Unity Drill Assembly Unit, .021 Green by Coltene/Whaledent, lnc. PDF, 778KB, File does not meet accessibility standards Date: 10. September 2018 Topics: Medical devices Type: Customer information

Product group Dental products - instruments
Reference 06947/18

Urgent Field Safety Notice for Accu-Chek Inform II, cobas h 232 POC, CoaguChek Pro II, CoaguChek XS Plus/XS Pro by Roche Diagnostics GmbH PDF, 482KB, File does not meet accessibility standards Date: 10. September 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - others
Reference 10894/18

Urgent Field Safety Notice for NOVA FA (POL YRAD PREMIUM CSAP) by SEDECAL S. A. PDF, 109KB, File does not meet accessibility standards Date: 10. September 2018 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 08306/18

Urgent Field Safety Notice for Aptio Automation / StremaLAB Automation by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 88KB, File does not meet accessibility standards Date: 10. September 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 10919/18

Urgent Field Safety Notice for Alinity s System by Abbott GmbH & Co. KG PDF, 102KB, File does not meet accessibility standards Date: 10. September 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 11088/18

Urgent Field Safety Notice for cobas e411 by Hitachi High-Technologies, Medical Systems QA Group PDF, 532KB, File does not meet accessibility standards Date: 10. September 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 10869/18

Urgent Field Safety Notice for Alinity hq Analyzer by Abbott GmbH & Co. KG PDF, 117KB, File does not meet accessibility standards Date: 10. September 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 10917/18

Urgent Field Safety Notice for Various brand of IV catheter by Mediplus (India) Linited PDF, 16MB, File does not meet accessibility standards Date: 06. September 2018 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 11227/18