Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Draeger Medical Systems, Inc., PR142097, Infinity Acute Care System .M540.

   Draeger Medical Systems, Inc. (DMSI) has become aware during testing in conjunction with our global market surveillance ...

   Wob-verzoek | 24-04-2024

2. Remote Diagnostic, FA-009, Tempus Pro

   Samenvatting: In de brief staat dat we een intermitterende softwarefout hebben ontdekt als onderdeel van een interne ...

   Waarschuwing | 07-02-2024

3. Remote Diagnostic Technologies Ltd., Tempus Pro

   An issue has been identified with the Tempus Pro Monitor where an error may occur during video laryngoscope use with the Tempus ...

   Waarschuwing | 05-01-2024

4. Remote Diagnostic Technologies Ltd., 2023-CC-EC-005-IR, Tempus Pro

   An issue has been identified with the Tempus Pro Monitor where an error may occur during video laryngoscope use with the Tempus ...

   Waarschuwing | 04-09-2023

5. Aesculap AG, FSCA 235, Synthetic vascular graft

   In the cause of an internal investigation Aesculap AG became aware of a product counterfeit of the UNI Graft K DV vascular ...

   Waarschuwing | 06-06-2019

6. Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Automated External Defibrillator

   De producten die door Mindray worden gedistribueerd zijn onderworpen aan voortdurende controles en we hebben een mogelijk ...

   Waarschuwing | 17-06-2024

7. Maquet Cardiopulmonary GmbH, 946576, BE-MECC 142000#NRP pack

   Maquet Cardiopulmonary GmbH (MCP) would like to inform you with this letter about a recall for the Custom Tubing Pack (CTP) ...

   Waarschuwing | 19-03-2024

8. Boston Scientific Corporation, 97174890-FA, POLARSHEATH Steerable Sheath

   Boston Scientific has identified a tooling error in manufacturing which may have caused delamination of the inner lumen of the ...

   Waarschuwing | 19-02-2024

9. PendraCare International B.V., 23-001, Convey Guiding Catheter

   The purpose of this letter is to notify you that PendraCare International B.V. is conducting a voluntary field action/removal for ...

   Waarschuwing | 29-08-2023

10. Datascope Corp., 2249723-06.02.2023-010-C, Cardiosave Intra-Aortic Balloon Pumps

    Datascope Corp., a subsidiary of Getinge is initiating a voluntary Medical Device Correction for the Cardiosave Hybrid and ...

    Waarschuwing | 18-08-2023