Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Change Healthcare Canada Company, PAE-05650, McKesson Cardiology Hemo, Change Healthcare Cardio

   A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate ...

   Waarschuwing | 02-09-2024

2. Aesculap AG, FSCA 235, Synthetic vascular graft

   In the cause of an internal investigation Aesculap AG became aware of a product counterfeit of the UNI Graft K DV vascular ...

   Waarschuwing | 06-06-2019

3. Cook Incorporated, 2024FA0008, Approach CTO and Approach Hydro ST Micro WireGuide

   Cook Medical heeft vastgesteld dat op de etiketten van hulpmiddelen uit de betrokken productpartijen onjuiste vervaldatums staan ...

   Waarschuwing | 21-10-2024

4. Equimedical BV, 2-2023, Equitamp and Equicel and equispon

   In March 2023 the Health and Youth Care Inspectorate (NL) received a compliance and enforcement request (CEF) fom Agentia ...

   Waarschuwing | 31-07-2023

5. NuMED, Inc., C-051, Z-MED II-X Catheter

   These units are being recalled due to them being manufactured with the incorrect balloon. The balloon that was placed on this ...

   Waarschuwing | 09-12-2024

6. M.A. Med Alliance SA, Cordis20241024, Selution SLR PTA Balloon Catheter

   Cordis has identified that there is potential for deflation difficulty or “slow deflation” of 4 lots of SELUTION SLRTM 018 PTA ...

   Waarschuwing | 18-11-2024

7. Medtronic, Inc., FA1368, LINQ II Insertable Cardiac Monitor

   DRINGENDE VEILIGHEIDSKENNISGEVING Een subset van Medtronic LINQ II™ insteekbare monitoringsystemen (LNQ22) Mogelijke ...

   Waarschuwing | 03-09-2024

8. Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Automated External Defibrillator

   De producten die door Mindray worden gedistribueerd zijn onderworpen aan voortdurende controles en we hebben een mogelijk ...

   Waarschuwing | 17-06-2024

9. Maquet Cardiopulmonary GmbH, 946576, BE-MECC 142000#NRP pack

   Maquet Cardiopulmonary GmbH (MCP) would like to inform you with this letter about a recall for the Custom Tubing Pack (CTP) ...

   Waarschuwing | 19-03-2024

10. Boston Scientific Corporation, 97174890-FA, POLARSHEATH Steerable Sheath

    Boston Scientific has identified a tooling error in manufacturing which may have caused delamination of the inner lumen of the ...

    Waarschuwing | 19-02-2024