Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. ALTATEC GmbH, 6189928, Knochenprofilfräser

   A physical examination of item number i5003.3350 revealed the sleeve is too tight to pass the profiler over the corresponding ...

   Waarschuwing | 02-11-2023

2. Swemac Innovation AB, Cannulated Drill for Metacarpal III. Large

   Cannulated diills with an incorrect measuring scale have been released to the market.

   Waarschuwing | 15-01-2025

3. Blue Belt Technologies, Inc, C-2024-03, Real Intelligence Cori

   Klanten ervaren mogelijk wisselend zicht op de REAL INTELLIGENCE-trackerarrays.

   Waarschuwing | 28-05-2024

4. Arthrex INC, R537_NL, Knee Scorpion™

   Associated outer labels and label content document for indicated batches display a sterility statement indicating “sterile” via ...

   Waarschuwing | 17-08-2023

5. Globus Medical, FSCA-2024-003, Cannula A, 9mm x 250mm, ExcelsiusGPS

   De hulpmiddelen kunnen mogelijk niet goed worden gesteriliseerd vanwege een interne opening die aanwezig kan zijn bij sommige ...

   Waarschuwing | 19-02-2024

6. Abbott Medical, FA-Q125-SH-1, Amplatzer TorqVue LP Delivery System / Catheter

   Abbott is begonnen met een vrijwillige terugroeping van bepaalde 4F Amplatzer™ TorqVue™ LP afgiftesysteem (TVLP) hulpmiddelen en ...

   Waarschuwing | 25-03-2025

7. Elekta Instrument AB, FCA-EIAB-0011, Disposable Biopsy Needle Kit

   Elekta is zich ervan bewust geworden dat de Disposable Biopsy Needles (911933) uit de hierboven vermelde batch (873874875R) ...

   Publicatie | 30-09-2024

8. Lohmann & Rauscher International GmbH & Co. KG, Suprasorb A+Ag Antimicrobial Ca-Alginate Dressing

   The date was incorrectly printed on the primary packaging. The sterile single packaging and the secondary packaging (for ...

   Waarschuwing | 22-01-2024

9. PEROUSE MEDICAL, CAPA23-051, POLYFILM

   A sealing problem on the packaging of the POLYFILM® has occurred. If the packaging of POLYFILM® has a defective sealing, it can ...

   Waarschuwing | 21-08-2023

10. Maquet Cardiovascular, 2242352-06/07/2024-001-R, Vasoview Hemopro Endoscopic Vessel Harvesting Sys.

    Maquet Cardiovascular, LLC (MCV), a subsidiary of Getinge, is initiating a voluntary Medical Device Removal for the VasoView ...

    Waarschuwing | 11-07-2024