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Urgent Field Safety Notice for Perceval Sutureless Aortic Valve by LivaNova Canada Corp. PDF, 80KB, File does not meet accessibility standards Date: 22. June 2018 Topics: Medical devices Type: Customer information

Product group Non-active implants - cardiac surgery
Reference 07039/18

Urgent Field Safety Notice for Sonderangefertigtes Katheterisierungsset Coro-Set für GFO Kliniken Bonn (St. Marien) by Smiths Medical ASD, lnc. PDF, 398KB, File does not meet accessibility standards Date: 22. June 2018 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 06396/18

Urgent Field Safety Notice for HistoCore Spectra S. by Leica Biosystems Nussloch GmbH PDF, 1MB, File does not meet accessibility standards Date: 22. June 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 07030/18

Urgent Field Safety Notice for CK-MB, opt. DGKC / IFCC; GLDH, DGKC by Dialab Ges.m.b.H. PDF, 252KB, File does not meet accessibility standards Date: 22. June 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 07220/18

Urgent Field Safety Notice for MRSASelect II by Bio-Rad Laboratories France PDF, 108KB, File does not meet accessibility standards Date: 22. June 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 06986/18

Urgent Field Safety Notice for Arrow HANDS-OFF Thermodilution Catheter by Arrow International Inc. PDF, 154KB, File does not meet accessibility standards Date: 22. June 2018 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 07481/18

Urgent Field Safety Notice for GTS Rasp Size +7 / GTS OHST Rasp Size +7 by Biomet France SARL PDF, 151KB, File does not meet accessibility standards Date: 21. June 2018 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 05646/18

Urgent Field Safety Notice for Discovery MR750w by GE Medical Systems, LLC PDF, 290KB, File does not meet accessibility standards Date: 21. June 2018 Topics: Medical devices Type: Customer information

Product group Electromedical fields - equipment for MR tomography
Reference 07438/18

Urgent Field Safety Notice for 1st gen. JOURNEY BCS fem. and tib. insert componen by Smith & Nephew, Inc., PDF, 108KB, File does not meet accessibility standards Date: 21. June 2018 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 07501/18

Urgent Field Safety Notice for Hydroline Trumpet Valve by Cardinal Health PDF, 90KB, File does not meet accessibility standards Date: 21. June 2018 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 07151/18

Urgent Field Safety Notice for Zementierter Müller Geradschaft by OHST Medizintechnik AG PDF, 85KB, File does not meet accessibility standards Date: 20. June 2018 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 03983/18

Urgent Field Safety Notice for RT-PLUS FEMORAL COMPONENT by Smith & Nephew Orthopaedics AG PDF, 175KB, File does not meet accessibility standards Date: 19. June 2018 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 00714/18

Urgent Field Safety Notice for FlexCardio Patient Monitoring System by Invivo Corporation (Philips Healthcare) PDF, 41KB, File does not meet accessibility standards Date: 19. June 2018 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 07401/18

Urgent Field Safety Notice for Phaseal Secondary Set, C61 by Becton Dickinson & Company PDF, 257KB, File does not meet accessibility standards Date: 19. June 2018 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion kits
Reference 07359/18

Urgent Field Safety Notice for FlexCardio Patient Monitoring System by Invivo Corporation (Philips Healthcare) PDF, 39KB, File does not meet accessibility standards Date: 19. June 2018 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 07356/18

Urgent Field Safety Notice for Arctic Sun Temperature Management System by Medivance, Inc. PDF, 65KB, File does not meet accessibility standards Date: 19. June 2018 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 07173/18

Urgent Field Safety Notice for ADV ANSYS by Newdeal SAS PDF, 628KB, File does not meet accessibility standards Date: 18. June 2018 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 06343/18

Urgent Field Safety Notice for HeartWare Ventricular Assist System by Heartware, Inc. PDF, 45KB, File does not meet accessibility standards Date: 18. June 2018 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - artificial hearts
Reference 05569/18

Urgent Field Safety Notice for SOPHIE by Fritz Stephan GmbH PDF, 2MB, File does not meet accessibility standards Date: 18. June 2018 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 06747/18

Urgent Field Safety Notice for 2-MET Urine ELISA Fast Track by LDN Labordiagnostika Nord GmbH & Co.KG PDF, 1MB, File does not meet accessibility standards Date: 15. June 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 03621/18

Urgent Field Safety Notice for AXIOM Aristos MX/VX by Siemens Healthcare GmbH, X-Ray Products (XP) PDF, 5MB, File does not meet accessibility standards Date: 15. June 2018 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 05882/18

Urgent Field Safety Notice for Vanguard Knee PS Tibial Bearing by Biomet Orthopaedic LLC PDF, 247KB, File does not meet accessibility standards Date: 15. June 2018 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 07269/18

Urgent Field Safety Notice for Trigo Sport by HASE-Spezialräder PDF, 1MB, File does not meet accessibility standards Date: 15. June 2018 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - functional diagnostics by way of gas exchange and exercise
Reference 07112/18

Urgent Field Safety Notice for Equinox Relieve, Equinox Advantage by O-Two Medical Technologies lnc. PDF, 615KB, File does not meet accessibility standards Date: 15. June 2018 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 05810/18

Urgent Field Safety Notice for Quava by Vermeiren N.V. PDF, 79KB, File does not meet accessibility standards Date: 14. June 2018 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - daily living aids
Reference 07189/18

Urgent Field Safety Notice for syngo.via by Siemens Healthcare GmbH, SYNGO (SY) PDF, 5MB, File does not meet accessibility standards Date: 14. June 2018 Topics: Medical devices Type: Customer information

Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 03360/18

Urgent Field Safety Notice for T5, T10-NT, ACSNT, Intera 0.5T/1.0T, 1.5T, Achieva by Philips Medical Systems Nederland B.V. PDF, 334KB, File does not meet accessibility standards Date: 14. June 2018 Topics: Medical devices Type: Customer information

Product group Electromedical fields - equipment for MR tomography
Reference 04409/18

Urgent Field Safety Notice for Halo skull pins by Össur hf. PDF, 225KB, File does not meet accessibility standards Date: 14. June 2018 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 07174/18

Urgent Field Safety Notice for schwarzer evo (EKG-Splitter ist Zubehör) by Schwarzer Cardiotek GmbH PDF, 2MB, File does not meet accessibility standards Date: 14. June 2018 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 06713/18

Urgent Field Safety Notice for Cirrus-14 Wire Guide AQ Hydrophilic Coating by William Cook Europe ApS PDF, 462KB, File does not meet accessibility standards Date: 13. June 2018 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 06762/18