Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. 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

2. 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

3. 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

4. Remote Diagnostic Technologies, 2022-CC-EC-017, Tempus Pro Patient Monitor

   However, testing revealed that the device does not meet the standards for Fluid and Particulate lngress.

   Waarschuwing | 08-03-2023

5. 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 | 06-03-2023

6. St. Jude Medical, FA-Q123-SH-2 Trifecta, Trifecta Valve Trifecta Valve w. Glide Technology

   Abbott verstrekt hierbij informatie betreffende structurele hartklepverslechtering (Structural Valve Deterioration, SVD)1 in ...

   Waarschuwing | 01-03-2023

7. Biosense Webster, 2220566, HELIOSTAR™ Balloon Ablation Catheter

   Biosense Webster has received complaints reporting Atrio-Esophageal Fistulas (AEF), while using the HELIOSTAR™ Balloon Ablation ...

   Waarschuwing | 28-02-2023

8. 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

9. Maquet Cardiopulmonary GmbH, 74922 . 745922, PLS Set; HLS Set Advanced5.0; HLS Set Advanced 7.0

   Maquet Cardiopulmonary GmbH (MCP) has received a communication from a regulatory body in which the conformity of the products ...

   Waarschuwing | 09-02-2023

10. 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