Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Update - Medtronic Navigation, Inc., FA1361, Neuroscience CST - StealthStation™ S8 App version 2.0 and 2.0.1

   Medtronic heeft een softwareprobleem geïdentificeerd in de StealthStation™ S8-app, softwareversies 2.0 en 2.0.1 dat kan optreden ...

   Waarschuwing | 09-02-2024

2. VOSTRA GmbH, 36063/23, U473, Rhinotamp und Rhinotamp latexfrei

   As part of the PMS activities, VOSTRA has become aware of a case of use with the product RHINOTAMP in which a user pulled on the ...

   Waarschuwing | 08-12-2023

3. Medtronic Navigation, Inc., FA1361, Neuroscience CST - StealthStation™ S8 App version 2.0 and 2.0.1

   Medtronic heeft een softwareprobleem geïdentificeerd in de StealthStation™ S8-app, softwareversies 2.0 en 2.0.1 dat kan optreden ...

   Waarschuwing | 06-10-2023

4. 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

5. Bard Access Systems Incorporated, PI-22-4510, Catheter Repair Kits

   BD treft momenteel een corrigerende maatregel inzake de veiligheid in het veld om specifieke loten van bepaalde katheter repair ...

   Waarschuwing | 01-12-2022

6. KARL STORZ SE & Co. KG 22-0002 - Single channel flexible endoscopes with T-Luer

   The correction is limited to a labeling update to correct the Instructions for Use for certain flexible endoscopes and advise ...

   Waarschuwing | 20-04-2022

7. Medtronic FA1205 - Stealth Autoguide™ Tracker

   The Stealth AutoguideTM Tracker interfaces with the StealthStation™ Navigation System. The Tracker holds and guides surgical ...

   Waarschuwing | 30-11-2021

8. Siemens Healthcare AX066_21_S - Sensis_Sensis Vibe systems VD1X SW

   The system operator manual states that the system should be rebooted once, every 7 days. In some cases, users are not following ...

   Waarschuwing | 24-11-2021

9. Advanced Bionics AG, FSN-3009511234‐02/17/20‐001R, HiRes Ultra CI and HiRes Ultra 3D CI

   Het kwaliteitssysteem van Advanced Bionics heeft een toegenomen aantal explantaties of mogelijke explantaties van het initiële ...

   Waarschuwing | 17-06-2020

10. GN Hearing A.S MS0028308 Resound, Beltone

    GN Hearing received reports from our manufacturing site in US regarding a software bug in our service & repair tool which ...

    Waarschuwing | 20-09-2019