Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Atrium Medical Corporation, 3011175548-02.15,.2023-001-C, Express Mini 500 Dry Seal Chest Drain

   Atrium/Getinge is initiating a voluntary Medical Device Correction for the Atrium Express Mini 500 Dry Seal Chest Drain. The ...

   Waarschuwing | 28-04-2023

2. GE Medical Systems Israel Ltd., FMI 76194, Vivid i Vivid q Vivid S5 Vivid S6

   GE Healthcare is zich ervan bewust geworden dat als de batterijen in bepaalde oude Vivid-systemen niet na 2 jaar worden ...

   Waarschuwing | 26-01-2023

3. Bolton Medical Inc, 2247858-12-06-2022-001R, RelayPro Thoracic Stent Graft System

   The Efficia External Paddles are intended to be used with the Efficia DFM100 and HeartStart Intrepid Monitor/Defibrillators – by ...

   Waarschuwing | 30-12-2022

4. Volcano Corporation, 2022-IGT-IGTD-001, PV.035 Digital IVUS Catheter

   Philips IGTD heeft een probleem vastgesteld met de gebruiksaanwijzing van de PV.035 digitale IVUS-katheter dat een risico kan ...

   Waarschuwing | 03-06-2022

5. BIOTRONIK, 200000470, Dynetic-35

   During an in-house inspection, Biotronik discovered that a few sterilization pouches of the Passeo-35 Xeo and Dynetic-35 were ...

   Waarschuwing | 03-12-2021

6. Boston Scientific Corporation, FSN-92630745-FA, LOTUS Edge Valve System

   Boston Scientific (BSC) voert een vrijwillige verwijdering van ongebruikte voorraad van het LOTUS™ Edge klepsysteem uit.

   Waarschuwing | 16-11-2020

7. William Cook Europe ApS, FSN-2020FA0005, Zenith Alpha® Abdominal Endovascular Graft

   Cook Medical has identified that specific lots of the Zenith Alpha® Abdominal Endovascular Graft (21MB main body) may contain ...

   Waarschuwing | 10-08-2020

8. The Spectranetics Corporation D055703 Bridge® Occlusion Balloon

   The Bridge Occlusion Balloon catheter is indicated for use for temporary vessel occlusion of the superior vena cava in ...

   Waarschuwing | 26-03-2020

9. Neovasc Inc. FCA 19-001-C - Neovasc Reducer

   Neovasc has discovered an error in the expiration date of the Reducer System Lot No. 190131-01. Since the Reducer Kit expiration ...

   Waarschuwing | 18-02-2020

10. Cordis Corporation Cordis20191113-OUS - PRECISE, S.M.A.R.T., S.M.A.R.T. Control

    Cordis became aware that the Instructions for Use (IFU) for the S.M.A.R.T. and PRECISE stents do not have correct language around ...

    Waarschuwing | 13-11-2019