Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Field Safety Notice: ARJOHUNTLEIGH, FLOWTRON ACS900

   It has been identified that in some instances the pump will constantly deliver pressure to the garment without triggering the ...

   Waarschuwing | 06-06-2017

2. Field Safety Notice: LivaNova Deutschland GmbH, Heater Cooler 3T

   LivaNova is issuing an updated Field Safety Notice to inform users about the retrofit of their Heater Cooler 3T devices. ...

   Waarschuwing | 03-05-2017

3. Field Safety Notice:REFLOW MEDICAL, Wingman 35 Crossing Catheter

   De Wingman 35 Crossing Catheter kan gevoelig zijn voor detachement Fabrikant: REFLOW MEDICAL Europees vertegenwoordiger: MediMark ...

   Waarschuwing | 20-04-2017

4. Field Safety Notice: Physio-Control, LIFEPAK 15 apparaat

   Physio-Control heeft kennis genomen van een probleem, waardoor het LIFEPAK 15 apparaat misschien geen defibrillatie-energie kan ...

   Waarschuwing | 21-02-2017

5. Boston Scientific 100000038229 - INGEVITY™ MRI pace,sense lead

   This letter provides important product performance information regarding a population of fifteen (15) Boston Scientific INGEVITY™ ...

   Waarschuwing | 02-12-2016

6. Atrium Medical Corporation, 3011175548-05/08/2024-001-R, Advanta VXT and Flixene Vascular Graft

   Between 27 December 2023 and 17 April 2024, Atrium Medical Corporation/Getinge received eight (8) complaints reporting that the ...

   Waarschuwing | 03-06-2024

7. MAQUET Cardiovascular LLC, 2242352-10/31/2023-006-R, Acrobat-i Vacuum Positioner System

   Maquet/Getinge received thirty-two (32) complaints between January 1, 2020, and September 19, 2023, reporting issues related to ...

   Waarschuwing | 28-11-2023

8. Atrium Medical Corporation, 3011175548-09/13/2023-001-R, Advanta V12 Covered Stent System

   Atrium/Getinge is initiating a voluntary Medical Device recall/removal for the Advanta V12 covered stent system due to an ...

   Waarschuwing | 02-11-2023

9. MAQUET Cardiovascular, LLC, 2242352-09/06/2023-004-R, MAQUET ACROBAT-i Vacuum Stabilizer System

   Maquet/Getinge is initiating a voluntary Medical Device Removal for the Acrobat-i Vacuum Stabilizer System due to a risk of the ...

   Waarschuwing | 03-10-2023

10. MAQUET Cardiovascular, LLC, 2242352-06/20/2023-003-R, ACCESSRAIL Platform and Acrobat Systems

    Maquet/Getinge is initiating a voluntary Medical Device Field Safety Notice-Removal for the ACCESSRAIL Platform Standard Blade ...

    Waarschuwing | 03-08-2023