Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. Cook Incorporated, FSN-2022FA0001, Hilal Embolization Microcoil, Nester® Embolization Microcoil, Tornado® Embolization Microcoil

   During manufacturing, Cook Medical identified that the loading cartridge included with Hilal Embolization Microcoils, Nester® ...

   Waarschuwing | 16-05-2022

10. Pulsion Medical Systems FSCA #605477 - NICCI Technology

    The blood pressure values displayed by the NICCI Technology can deviate widely from the expected values. This value deviation has ...

    Waarschuwing | 11-05-2022