Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. High Technology Products_Cocoon Medical MEDDEV2.12_HTP_02 - Cooltech

   Paradoxical adipose hyperplasia has been included in the latest version of the cooltech's User Manual with reference number ...

   Waarschuwing | 10-07-2019

2. Hamilton Medical AG, FSN-CER 101091, HAMILTON-C6

   Safety ventilation can be triggered by switching to an adaptive mode. The display can be restarted by changing the Target Shift ...

   Waarschuwing | 09-03-2023

3. SenTec AG, FSN-CAPA-003, SenTec Digital Monitor

   Sentec start een corrigerende actie om klanten te informeren over een non-conformiteit van de Sente c Digital Monitor (SDM).

   Waarschuwing | 10-12-2020

4. 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

5. Teleflex Inc., EIF-000533, Aquapak Humidifier Reservoir with Adaptor; Hudson RCI Humidifier Adaptor

   Medline heeft een veiligheidswaarschuwing utgevaardigd voor de hierboven vermelde productcodes van de Hudson RCI® AQUAPAK® ...

   Waarschuwing | 07-09-2023

6. 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

7. 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

8. 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

9. Scaleo Medical, NCP116, HORIZON P5

   We have been informed that on some instances when running at max setting 5 for 2 hours and at external environment temperature ...

   Waarschuwing | 31-08-2023

10. Hamilton Medical AG, FSCA 2023-07-03, HAMILTON-C1, HAMILTON-T1, HAMILTON-MR1

    A degrading capacitor on the control board might leak electrolyte onto the control board, causing a short circuit on the board ...

    Waarschuwing | 21-08-2023