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FAQ and contact persons Date: 12. May 2023 Topics: Medical devices Type: Article

In the following you will find answers to the most frequently asked questions in the field of medical devices as well as contact information on various subjects.

Urgent Field Safety Notice for Dilatation balloon (DIL1-A1-Series) by FUJIFILM medwork GmbH PDF, 1MB, File does not meet accessibility standards Date: 12. May 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 07172/23

Urgent Field Safety Notice for Sonicaid Team3 by Huntleigh Healthcare Ltd. Diagnostics PDF, 8MB, File does not meet accessibility standards Date: 12. May 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 09761/23

Urgent Field Safety Notice for VitreQ by Vitreq B.V. PDF, 135KB, File does not meet accessibility standards Date: 11. May 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - eye surgery
Reference 13396/23

Urgent Field Safety Notice for Medistrip by Neuromedex GmbH PDF, 1MB, File does not meet accessibility standards Date: 09. May 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - vascular surgery
Reference 12352/23

Urgent Field Safety Notice for PLASMACELL-C disposable set by Fresenius Kabi AG PDF, 134KB, File does not meet accessibility standards Date: 08. May 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - equipment for collecting blood products and peripheral stem cells
Reference 11680/23

Urgent Field Safety Notice for EliA GliadinDP IgG Well by Phadia AB PDF, 177KB, File does not meet accessibility standards Date: 05. May 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 12052/23

Urgent Field Safety Notice for 3Dose Syringe by BIMED TEKNIK ALETLER SANAYI VE TICARET A.S. PDF, 116KB, File does not meet accessibility standards Date: 05. May 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Reference 10893/23

Urgent Field Safety Notice for SINGLE USE REPOSITIONABLE CLIP HX-202LR/UR by Olympus Medical Systems Corp. PDF, 276KB, File does not meet accessibility standards Date: 05. May 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - general instruments
Reference 11691/23

Urgent Field Safety Notice for BARRIER TUR Set by Mölnlycke Health Care AB PDF, 1MB, File does not meet accessibility standards Date: 05. May 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 12047/23

Urgent Field Safety Notice for NE'X Glue Surgical Adhesive by Grena Biomed Limited PDF, 1MB, File does not meet accessibility standards Date: 04. May 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 35359/22

Urgent Field Safety Notice for Linear Accelerator (Varex PSU) by Elekta Ltd PDF, 166KB, File does not meet accessibility standards Date: 04. May 2023 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiation facilites with accelerators for teletherapy
Reference 12798/23

Urgent Field Safety Notice for VENTRALIGHT S. Mesh with ECHO PS Positioning System by Davol Inc. PDF, 427KB, File does not meet accessibility standards Date: 04. May 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 12502/23

Urgent Field Safety Notice for NextSeq 550Dx Instrument / MiSeq Dx Instrument by Illumina, Inc. PDF, 1MB, File does not meet accessibility standards Date: 04. May 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 12357/23

Urgent Field Safety Notice for Alinity i Anti-TPO Reagent Kit by Abbott Ireland Diagnostics Division PDF, 173KB, File does not meet accessibility standards Date: 04. May 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 12197/23

Urgent Field Safety Notice for Arrow AutoCAT Intra-Aortic Balloon Pump (IABP) Series, AC3T Series IABP System by Teleflex Medical USA PDF, 639KB, File does not meet accessibility standards Date: 03. May 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 11918/23

Urgent Field Safety Notice for TAKE-APART Bipolar Spring or Ring Handle by Karl Storz S. & Co KG PDF, 525KB, File does not meet accessibility standards Date: 02. May 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 11958/23

Urgent Field Safety Notice for Cardiosave Hybrid/Rescue IABP by Maquet (vorher: Datascope Corp) PDF, 497KB, File does not meet accessibility standards Date: 02. May 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 07192/23

Urgent Field Safety Notice for Behandlungsstuhl 500 XLE by UFSK-International OSYS GmbH PDF, 1MB, File does not meet accessibility standards Date: 02. May 2023 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - furnishings
Reference 11684/23

Urgent Field Safety Notice for exoplan by exocad GmbH PDF, 1MB, File does not meet accessibility standards Date: 29. April 2023 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) - software for computer-based treatment
Reference 11938/23