Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Medtronic, FA1326, Cobalt™ XT/Cobalt™/Crome™ ICDs and CRT-Ds

   Een software-update voor de CareLink™ SmartSync™hulpmiddelmanager (SmartSync) is nu beschikbaar. Deze update voor SmartSync stemt ...

   Waarschuwing | 15-03-2024

2. KARL STORZ SE & Co. KG, FSN-200862444, Filter, Insufflation

   Deze veiligheidswaarschuwing maakt onderdeel uit van een groter Europees onderzoek naar vervalste certificaten. Doordat de ...

   Waarschuwing | 19-05-2021

3. Abiomed Inc., 2023-FA-00156 / 2023-FA-00157, Impella CP Impella 5.5 Impella RP Impella 5.0

   Abiomed discovered that information on safe use of lmpella pumps were issued with two technical bulletins (a.k.a. lmpella Product ...

   Waarschuwing | 26-02-2024

4. Parker Laboratories, Inc, 2212018-01/17/2024-001-R, Tensive Conductive Adhesive Gel

   Parker Laboratories, Inc. is conducting a voluntary recall of the above product. The reason for this recall is the viscosity of ...

   Waarschuwing | 25-01-2024

5. NVT GmbH, FSN-CAPA 23-10, ALLEGRA Transcatheter Heart Valve

   NVT has been informed that there has been a mix-up between an ALLEGRA THV 23 and an ALLEGRA THV 31.lf not identified prior to ...

   Waarschuwing | 11-07-2023

6. Medtronic Inc., FA1186, DLP Left Heart Vent

   The purpose of this letter is to advise you that Medtronic is voluntarily recalling specific models of unused DLP® Left Heart ...

   Waarschuwing | 25-08-2021

7. Medtronic CoreValve LLC,FSN-FA977, Medtronic CoreValveTM EvolutTM R System, Medtronic CoreValveTM EvolutTM PRO System

   Dringende veiligheidskennisgeving EnVeo™ R- en EnVeo™ PRO-plaatsingskatheter. Geproduceerd vóór 11 juli 2020 of in partij ...

   Waarschuwing | 11-06-2021

8. EKOS Corp, 19-002, EKOS Control System 4.0

   EKOS™ Corporation geeft deze ‘Field Safety Notice’ af om gebruikers te attenderen op het correct gebruik en opslag condities voor ...

   Waarschuwing | 20-05-2019

9. Endologix, FS-0011, Nellix EndoVascular Aneurysm Sealing System

   Endologix is voluntarily ceasing sales, effective immediately, and requesting the return of all unused Nellix Systems due to ...

   Waarschuwing | 04-01-2019

10. Field Safety Notice: Argon Medical Devices, Argon Arterial Access Needle

    Argon Medical has received a complaint from one of our distributors of a potential packaging defect. Fabrikant: Argon Medical ...

    Waarschuwing | 24-05-2017