Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. BIOTECK SPA, FSCA REF: 230307, BIO-GEN/GRANULES

   The falsified devices bear the name BIO-GEN® and the indication of Bioteck SpA as the manufacturer but have packaging ...

   Waarschuwing | 29-03-2023

2. Megadyne Reusable Return Electrodes, FSN-2257672, Electrosurgical return electrode, reusable

   Hulpmiddelen voor het manipuleren en herstellen van lichaamsweefsels GMDN, Elektrode voor elektrochirurgisch diathermiesysteem ...

   Waarschuwing | 13-06-2023

3. Intuitive Surgical ISIFA2022-01-C - da Vinci X/XI Vessel Sealer Extend and SynchroSeal Instruments

   Deze veiligheidsmededeling is bedoeld om u erop te wijzen dat Intuitive zich ervan bewust is geworden dat het plaatsen van ...

   Waarschuwing | 15-03-2022

4. Atrium Medical Corporation, 3011175548-09/13/2023-001-R, Advanta V12 Covered Stent System

   Atrium/Getinge is initiating a voluntary Medical Device recall/removal for the Advanta V12 covered stent system due to an ...

   Waarschuwing | 02-11-2023

5. MAQUET Cardiovascular, LLC, 2242352-09/06/2023-004-R, MAQUET ACROBAT-i Vacuum Stabilizer System

   Maquet/Getinge is initiating a voluntary Medical Device Removal for the Acrobat-i Vacuum Stabilizer System due to a risk of the ...

   Waarschuwing | 03-10-2023

6. MAQUET Cardiovascular LLC, 2242352‐02.17.2023‐002‐R, Hemopro 2

   Maquet Cardiovascular, LLC/Getinge was notified by their sterilization provider (Steris) that for a period of roughly five ...

   Waarschuwing | 21-04-2023

7. VitreQ B.V., PRE-20220006, CryoTreQ

   Vitreq B.V. has become aware of two incidents which described that a CryoTreq device suddenly and forcefully disassembled after ...

   Waarschuwing | 15-03-2023

8. Aesculap AG, FSCA 266, Nasal snare single-use

   Aesculap AG as a legal manufacturer has voluntarily decided to recall the affected products under point 1.2 as a precaution due ...

   Waarschuwing | 30-12-2022

9. EUROS SAS, FSN-FSCA-2021-02, NEMOST - Growing Domino - Ø5.5mm

   Following trend analysis in complaints related to NEMOST device, EUROS has decided to issue a voluntary safety notice to all ...

   Waarschuwing | 31-12-2021

10. VitreQ, PRE-20210004, VitreQ

    VitreQ B.V. is issuing this Field Safety Notice to make you aware of a mislabeling of three vitreoretinal 25G Disposable Micro ...

    Waarschuwing | 05-12-2021