Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Medtronic B.V., FA1265, HeartWare Ventricular Assist Device HVAD System

   Het doel van deze brief is om u te informeren dat de wijziging van de batterijconfiguratiemodus om het probleem van elektrische ...

   Waarschuwing | 16-06-2023

2. Philips Medizin Systeme Boblingen GmbH, FSCA 2023-CC-HPM-006, Patient Information Center iX

   Philips has become aware of a potential compliance issue with the Philips Patient Information Center (PIC iX) and IntelliVue MX40 ...

   Waarschuwing | 25-05-2023

3. Datascope Corp., 2249723-01/24/2023-004-C, Cardiosave Intra-Aortic Balloon Pumps

   There have been reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting resulting in ...

   Waarschuwing | 11-04-2023

4. Datascope Corp, 2249723-01/24/2023-003-C, Cardiosave Intra-Aortic Balloon Pumps

   There have been reported failures of the high pressure helium regulator which may cause a helium leak in the Cardiosave Hospital ...

   Waarschuwing | 16-03-2023

5. Datascope Corp., 2249723-01/24/2023-002-C, Cardiosave Intra-Aortic Balloon Pumps

   As part of an ongoing investigation into unexpected shutdown of the Cardiosave IABP, the Datascope/Getinge Investigation team ...

   Waarschuwing | 16-03-2023

6. Physio-Control, RA2023- 3211897, LIFEPAK® CR2 DEFIBRILLATOR

   Stryker has discovered through customer complaints that some cellular LIFEPAK CR2 devices have incorrect cellular settings.  

   Waarschuwing | 09-02-2023

7. St. Jude Medical, FA-Q123-HF-2 Sensor Operating, CardioMEMS PA Sensor and Delivery System

   The CardioMEMS HF System is intended to operate at frequencies between 30 and 37.5 MHz. Abbott has found that a small number ...

   Waarschuwing | 09-02-2023

8. Osypka AG, FSCA_002_NCR_155_2022, Cardiac valvuloplasty catheter

   Based on customer feedback, we have determined that a mix-up occurred during the labelling process for these products.

   Waarschuwing | 21-12-2022

9. HeartWare Inc., FA1293, HeartWare™ Ventricular Assist Device (HVAD™) System Hardened Driveline Cover.

   Medtronic maakt u attent op belangrijke veiligheidsinformatie over de kap van de aandrijflijncontroller van het HVAD™- systeem. ...

   Waarschuwing | 14-12-2022

10. GE Medical Systems Information Technologies, Inc., FSN-FMI 36153, Carescape Central Station

    The CARESCAPE Central Station (CSCS) V2 can shut down due to a potential power supply component failure. This can lead to loss of ...

    Waarschuwing | 22-08-2022