Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Remote Diagnostic Technologies Ltd., Tempus Pro

   An issue has been identified with the Tempus Pro Monitor where an error may occur during video laryngoscope use with the Tempus ...

   Waarschuwing | 05-01-2024

2. Remote Diagnostic Technologies Ltd., 2023-CC-EC-005-IR, Tempus Pro

   An issue has been identified with the Tempus Pro Monitor where an error may occur during video laryngoscope use with the Tempus ...

   Waarschuwing | 04-09-2023

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. Draeger Medical System, Inc., PR151781, Infinity CentralStation

   During our global market surveillance activities, we have become aware of instances where the new Edifier speakers (shipped in or ...

   Waarschuwing | 24-02-2025

6. Spectrum Medical S.r.l., CACP0125, Quantum Perfusion Centrifugal Blood Pump

    Spectrum Medical S.r.l., als fabrikant van de Quantum Perfusie Centrifugale Bloedpomp met Geïntegreerde Druksensoren Lange ...

   Waarschuwing | 27-01-2025

7. 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

8. 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

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

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

   Waarschuwing | 03-09-2024

10. 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