Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Maquet Cardiopulmonary GmbH, 946521, H 31471#Hemoconcentrator Set BC 140 / H 15981#Set BC 140 Plus

   The component "Hemoconcentrator" was assembled into the finished product (Hemoconcentrator tubing set) after its shelf-life had ...

   Waarschuwing | 23-01-2024

2. Boston Scientific Corporation, 98973760-FA, Guider Softip XF Guide catheters

   Stryker Neurovascular has observed that certain lots of Guider Softip™ XF Guide Catheters appear to have the incorrect tip curve ...

   Waarschuwing | 13-10-2023

3. Berlin Heart GmbH, DS-23-01, EXCOR Cannula

   Berlin Heart dringt er bij u op aan om goed op de integriteit van de canule te letten en op situaties waarbij onjuist gebruik of ...

   Waarschuwing | 14-09-2023

4. Datascope Corp., 2249723-06.02.2023-009-C, Cardiosave Intra-Aortic Balloon Pumps

   Datascope Corp., a subsidiary of Getinge is initiating a voluntary Medical Device Correction for the Cardiosave Hybrid and ...

   Waarschuwing | 17-08-2023

5. Arrow International LLC, EIF-000522, Arrow AutoCAT Intra-Aortic Balloon Pump IABP Series

   Teleflex has received complaints reporting that some users of the affected IABP devices have experienced short battery run-times, ...

   Waarschuwing | 01-05-2023

6. GS Elektromedizinische Geräte G. Stemple GmbH, VGL-21984, corpuls3

   Bij gebruik van de therapiefuncties in de AED-modus in combinatie met de geactiveerde functie "Auto Analyse" en speciale ...

   Waarschuwing | 11-04-2023

7. Datascope Corp., FSN-2249723-02/02/2023-005-C, Cardiosave Intra-Aortic Balloon Pumps

   Datascope/Getinge has identified that, while conducting Safety Disk testing, expired tubing was used on the test fixture ...

   Waarschuwing | 23-03-2023

8. MicroPort CRM S.r.l., CRM-SAL-2023-001, ENO TEO OTO KORA 250

   Per 23 Februari 2023, heeft MicroPort CRM zes (6) bevestigde klachten ontvangen betreffende een abnormale stijging van de ...

   Waarschuwing | 13-03-2023

9. Datascope Corp. Getinge, 2249723-11.16.2022-001-C, Cardiosave Intra-Aortic Balloon Pumps

   Datascope Corp., a subsidiary of Getinge, is initiating a voluntary Medical Device Correction for the Cardiosave Hybrid and ...

   Waarschuwing | 30-12-2022

10. Heater Cooler B.V., 2072095, HCTronic

    We would like to inform you about a software bug we found because of feedback we received on 21 November 2022.

    Waarschuwing | 09-12-2022