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Urgent Field Safety Notice for SuperCore Semi-Automatic Biopsy Instrument by Argon Medical Devices, Inc. PDF, 170KB, File does not meet accessibility standards Date: 11. November 2021 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - general instruments
Reference 22034/21

Urgent Field Safety Notice for GenoType MTBDRplus V. 2.0 / GenoType MTBDRsl V.2. by Hain Lifescience GmbH PDF, 691KB, File does not meet accessibility standards Date: 11. November 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 25080/21

Urgent Field Safety Notice for Dimension Vista Systems by Siemens Healthcare Diagnostics Inc.- Glasgow PDF, 91KB, File does not meet accessibility standards Date: 11. November 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 25078/21

Urgent Field Safety Notice for INNOVANCE LOCI Control 1, INNOVANCE LOCI Control 2 by Siemens Healthcare Diagnostics Products GmbH PDF, 158KB, File does not meet accessibility standards Date: 11. November 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 24668/21

Urgent Field Safety Notice for RapiD 20 E by BioMérieux SA PDF, 795KB, File does not meet accessibility standards Date: 11. November 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 24525/21

Urgent Field Safety Notice for UROMED SILUCENT, UROMED PROSIL, Transurethral Silicone Balloon Catheter by UROMED Kurt Drews KG PDF, 88KB, File does not meet accessibility standards Date: 11. November 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 24501/21

Urgent Field Safety Notice for MY01 Continuous Compartmental Pressure Monitor by MY01 Inc. PDF, 847KB, File does not meet accessibility standards Date: 11. November 2021 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 13085/21

Urgent Field Safety Notice for Sonosid Ultraschallgel by Asid Bonz GmbH PDF, 39KB, File does not meet accessibility standards Date: 11. November 2021 Topics: Medical devices Type: Customer information

Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 25188/21

Urgent Field Safety Notice for MiniMed 640G pump, MiniMed 670G pump by Medtronic Minimed PDF, 177KB, File does not meet accessibility standards Date: 10. November 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 15948/19

Urgent Field Safety Notice for MiniMed remote controller by Medtronic Minimed PDF, 136KB, File does not meet accessibility standards Date: 10. November 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 10052/18

Urgent Field Safety Notice for Surgical Gowns by Medline International France SAS PDF, 635KB, File does not meet accessibility standards Date: 10. November 2021 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 25077/21

Urgent Field Safety Notice for Leica M220 F12 by Leica Microsystems (Schweiz) AG PDF, 225KB, File does not meet accessibility standards Date: 10. November 2021 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - medical microscopes (does not incude laboratory microscopes)
Reference 24116/21

Urgent Field Safety Notice for ComposiTCP 30 Interference screw - D 7- L:25 mm; cannula 1.2m by SBM SAS PDF, 435KB, File does not meet accessibility standards Date: 10. November 2021 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 24994/21

Urgent Field Safety Notice for RelayPro Thoracic Stent Graft System by Bolton Medical lnc. PDF, 714KB, File does not meet accessibility standards Date: 10. November 2021 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 21470/21

Urgent Field Safety Notice for Vista 120 & Vista Central Monitoring Station (CMS) by Drägerwerk AG & Co. KGaA PDF, 2MB, File does not meet accessibility standards Date: 10. November 2021 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 19020/21

Urgent Field Safety Notice for IMMULITE Systems AlaTOP Allergy Screen by Siemens Healthcare Diagnostics Products Ltd. PDF, 80KB, File does not meet accessibility standards Date: 09. November 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 20443/21

Urgent Field Safety Notice for Biograph mCT by Siemens Medical Solutions USA, Inc. Molecular Imaging PDF, 287KB, File does not meet accessibility standards Date: 09. November 2021 Topics: Medical devices Type: Customer information

Product group Radiological technology - equipment for nuclear medical functional and localisation diagnostics
Reference 24750/21

Urgent Field Safety Notice for SURGICAL LOOP SILICONE YELLOW by B. Braun Surgical S.A. PDF, 813KB, File does not meet accessibility standards Date: 09. November 2021 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - surgical sutures, vascular loops etc.
Reference 24745/21

Urgent Field Safety Notice for mylife App by SINOVO health solutions GmbH PDF, 65KB, File does not meet accessibility standards Date: 09. November 2021 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) - medical apps
Reference 24089/21

Urgent Field Safety Notice for Amplatzer Vascular Plug II by S.. Jude Medical, Inc.jetzt Abbott Plymouth PDF, 163KB, File does not meet accessibility standards Date: 09. November 2021 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 23577/21

Urgent Field Safety Notice for HeartMate Touch Kit by Thoratec Corporation PDF, 21KB, File does not meet accessibility standards Date: 09. November 2021 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - programming and control equipment
Reference 23802/21

Urgent Field Safety Notice for Q400F / Q500F by Sunrise Medical GmbH & Co. KG PDF, 168KB, File does not meet accessibility standards Date: 09. November 2021 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - mobility aids
Reference 22956/21

Urgent Field Safety Notice for Beaver Xstar and CustomEyes by Beaver Visitec International, Ltd PDF, 407KB, File does not meet accessibility standards Date: 09. November 2021 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - eye surgery
Reference 22501/21

Urgent Field Safety Notice for GyneFix by Contrel Europe nv PDF, 245KB, File does not meet accessibility standards Date: 09. November 2021 Topics: Medical devices Type: Customer information

Product group Contraception - intrauterine device
Reference 22263/21

Urgent Field Safety Notice for ARCHITECT c4000 & ARCHITECT i2000 by Abbott Laboratories (Abbott Park) PDF, 191KB, File does not meet accessibility standards Date: 09. November 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 21881/21

Urgent Field Safety Notice for PRECICE System by NuVasive Specialized Orthopedics, Inc., a division of NuVasive, Inc. PDF, 195KB, File does not meet accessibility standards Date: 09. November 2021 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - others
Reference 01857/21

Urgent Field Safety Notice for Pericardial Sucker (Sump) by free life medical GmbH PDF, 2MB, File does not meet accessibility standards Date: 09. November 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Reference 24767/21

Urgent Field Safety Notice for APTIO Automation by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 109KB, File does not meet accessibility standards Date: 05. November 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 22407/21

Urgent Field Safety Notice for D513 Disposable Waste Container for the ABL800 FLEX by Radiometer Medical ApS PDF, 153KB, File does not meet accessibility standards Date: 05. November 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 22285/21

Urgent Field Safety Notice for HemosIL ReadiPlasTin by Instrumentation Laboratory Co. PDF, 224KB, File does not meet accessibility standards Date: 05. November 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 22166/21