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Urgent Field Safety Notice for QUANTIA RF by Biokit S. A. PDF, 34KB, File does not meet accessibility standards Date: 10. May 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 05131/19

Urgent Field Safety Notice for PRECISION Spinal Cord Stimulator (SCS) System and VerciseT Deep Brain Stimulation (DBS) System by Boston Scientific Neuromodulation Corporation PDF, 173KB, File does not meet accessibility standards Date: 10. May 2019 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - biostimulators
Reference 05289/19

Urgent Field Safety Notice for MX40 Intellivue by Philips Medical Systems PDF, 314KB, File does not meet accessibility standards Date: 10. May 2019 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 05190/19

Urgent Field Safety Notice for CT-Scanner by GE Healthcare, Healthcare Systems PDF, 128KB, File does not meet accessibility standards Date: 10. May 2019 Topics: Medical devices Type: Customer information

Product group Radiological technology - CT scanners
Reference 16163/18

Urgent Field Safety Notice for Swan-Ganz True Size Flow-Directed Monitoring Cat. by Edwards Lifesciences LLC PDF, 294KB, File does not meet accessibility standards Date: 10. May 2019 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 06031/19

Urgent Field Safety Notice for PASCAL Transcatheter Mitral Valve Repair System by Edwards Lifesciences LLC PDF, 2MB, File does not meet accessibility standards Date: 09. May 2019 Topics: Medical devices Type: Customer information

Product group Non-active implants - cardiac surgery
Reference 05791/19

Urgent Field Safety Notice for Straumann TempImplant ø 2.0mm, L 12.0mm, Ti by Institut Straumann AG PDF, 27KB, File does not meet accessibility standards Date: 09. May 2019 Topics: Medical devices Type: Customer information

Product group Dental products - dental implants
Reference 05674/19

Urgent Field Safety Notice for Select Myoelectric Hand by Hugh Steeper Ltd PDF, 397KB, File does not meet accessibility standards Date: 09. May 2019 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - prostheses (exoprostheses)
Reference 03882/19

Urgent Field Safety Notice for Mobile S., Ergothan by Medical Service GmbH PDF, 169KB, File does not meet accessibility standards Date: 09. May 2019 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 05801/19

Urgent Field Safety Notice for MitraClip NTR/XTR by Abbott Vascular Evalve Inc. PDF, 372KB, File does not meet accessibility standards Date: 08. May 2019 Topics: Medical devices Type: Customer information

Product group Non-active implants - cardiac surgery
Reference 05532/19

Urgent Field Safety Notice for Kwart Retro-Inject Ureteral Stent Set / Salle Intraoperative Pyeloplasty Stent Set by Cook Incorporated PDF, 96KB, File does not meet accessibility standards Date: 08. May 2019 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 05600/19

Urgent Field Safety Notice for IRATHERM1000 by Von Ardenne Institut für Angewandte Medizinische Forschung GmbH PDF, 213KB, File does not meet accessibility standards Date: 08. May 2019 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 04628/19

Urgent Field Safety Notice for CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM by Aesculap AG PDF, 254KB, File does not meet accessibility standards Date: 08. May 2019 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 05598/19

Urgent Field Safety Notice for EnCor Breast Biopsy Probe by SenoRx, Inc. PDF, 240KB, File does not meet accessibility standards Date: 07. May 2019 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 05680/19

Urgent Field Safety Notice for MAHURKAR and Argyle Acute Hemodialysis Catheters by Covidien llc PDF, 68KB, File does not meet accessibility standards Date: 07. May 2019 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 05700/19

Urgent Field Safety Notice for M300 by Draeger Medical Systems, Inc PDF, 3MB, File does not meet accessibility standards Date: 07. May 2019 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 08425/18

Urgent Field Safety Notice for ACDA Antikoagulanzlösung by Maco Pharma International GmbH PDF, 331KB, File does not meet accessibility standards Date: 07. May 2019 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - equipment for collecting blood products and peripheral stem cells
Reference 05379/19

Urgent Field Safety Notice for TAPES by Endo Tools Therapeutics SA PDF, 108KB, File does not meet accessibility standards Date: 06. May 2019 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - general instruments
Reference 05260/19

Urgent Field Safety Notice for Tristel Rinse Wipe by Tristel Solutions Ltd PDF, 916KB, File does not meet accessibility standards Date: 06. May 2019 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - cleaning / disinfection / sterilisation
Reference 05487/19

Urgent Field Safety Notice for WiSE CRT Electrode and Delivery Catheter by EBR Systems Inc. PDF, 590KB, File does not meet accessibility standards Date: 06. May 2019 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - cardiac pacemakers
Reference 05621/19

Urgent Field Safety Notice for Wombat Living by R82 A/S PDF, 169KB, File does not meet accessibility standards Date: 06. May 2019 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - daily living aids
Reference 03974/19

Urgent Field Safety Notice for VENTICA skin electrode by Icare Finland Oy PDF, 128KB, File does not meet accessibility standards Date: 06. May 2019 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - pulmonary function diagnostics
Reference 04061/19

Urgent Field Safety Notice for twinSys impactor with offset by Mathys AG Bettlach PDF, 140KB, File does not meet accessibility standards Date: 03. May 2019 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 05620/19

Urgent Field Safety Notice for Xenform - Uphold - Polyform - Pinnacle by Boston Scientific Corporation Marlborough PDF, 139KB, File does not meet accessibility standards Date: 03. May 2019 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 05570/19

Urgent Field Safety Notice for BVI OPHTHALMIC FLUID CONTROL SPONGES by Beaver-Visitec International, Inc PDF, 412KB, File does not meet accessibility standards Date: 03. May 2019 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - swabs, sponges, wipes, swabsticks
Reference 05535/19

Urgent Field Safety Notice for NI-C311 Energy Hybrid Knie by Nabtesco Corporation PDF, 288KB, File does not meet accessibility standards Date: 03. May 2019 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - prostheses (exoprostheses)
Reference 05193/19

Urgent Field Safety Notice for Alvarado Knee Holder by Zimmer Orthopaedic Surgical Products PDF, 342KB, File does not meet accessibility standards Date: 03. May 2019 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 05603/19

Urgent Field Safety Notice for Maestro by Ortho Organizers, Inc. PDF, 362KB, File does not meet accessibility standards Date: 02. May 2019 Topics: Medical devices Type: Customer information

Product group Dental products - orthodontic equipment
Reference 04546/19

Urgent Field Safety Notice for Zenith Alpha Abdominal Endovascular Graft - ZIMB ZLC ZLBE ZISL by William Cook Europe ApS PDF, 1MB, File does not meet accessibility standards Date: 02. May 2019 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 05446/19

Urgent Field Safety Notice for Heat exchanger and infusion s.t.- TEIDE 150 by CAIR LGL PDF, 79KB, File does not meet accessibility standards Date: 02. May 2019 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 05451/19