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Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

538 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. 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

  2. Maquet Cardiopulmonary GmbH, 781869, QUADROX-i.-iD, VHK 11000, VKMO 10000.11000

    Maquet Cardiopulmonary GmbH (MCP) became aware of various failure modes in regard to the QUADROX-i/ -iD, VHK 11000 and VKMO ...

    Waarschuwing | 23-03-2023

  3. 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

  4. 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

  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 | 13-03-2023

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

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