Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
538 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
- Datum
- Relevantie
-
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 ...
-
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 ...
-
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 ...
-
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 ...
-
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 ...
-
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.
-
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 ...
-
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 ...
-
Biosense Webster, 2220566, HELIOSTAR™ Balloon Ablation Catheter
Biosense Webster has received complaints reporting Atrio-Esophageal Fistulas (AEF), while using the HELIOSTAR™ Balloon Ablation ...
-
Physio-Control, RA2023- 3211897, LIFEPAK® CR2 DEFIBRILLATOR
Stryker has discovered through customer complaints that some cellular LIFEPAK CR2 devices have incorrect cellular settings.