Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. 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

2. Lowenstein Medical Technology GmbH, LM150TD

   In rare cases, an internal communication problem between the ventilator's controllers may result in ventilation being ...

   Waarschuwing | 03-01-2024

3. Welch Allyn, Inc, FA-2023-055, Qstress 6, Xscribe 6

   Baxter Healthcare Corporation is issuing a Correction for the Q‐ Stress and XScribe Cardiac Stress Testing Systems (Q‐Stress ...

   Waarschuwing | 15-12-2023

4. Maquet Critical Care AB, MCC-23-002-IU, Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e

   Internal tests at Getinge have revealed a cybersecurity related vulnerability which potentially could lead to Denial of Service ...

   Waarschuwing | 15-12-2023

5. Philips Respironics, Inc., 2023-CC-SRC-011, Trilogy Evo and Trilogy Evo O2 ventilators

   During an internal review of the Trilogy Evo and Trilogy Evo O2 Ventilators Instructions for Use (IFUs) manuals, Philips ...

   Waarschuwing | 01-12-2023

6. Hamilton Medical AG, HAMILTON-C1, HAMILTON-T1, HAMILTON-C2, HAMILTON-C3

   We have become aware of a malfunction with our HAMILTON-C2/C3/C1/T1 ventilators  when used long term in neonatal patient group.

   Waarschuwing | 20-11-2023

7. ResMed Pty Ltd, AirFit N10.N20.F20.F20NV.F30.F30i-AirTouch N20.F20

   ResMed werkt de Contra-indicaties en Waarschuwing met betrekking tot magnetische interferentie bij de gebruikershandleidingen ...

   Waarschuwing | 16-11-2023

8. Medtronic Xomed, Inc., FA1369, NIM Trivantage™ EMG Endotracheal tube

   Met deze brief willen wij u informeren dat Medtronic specifieke productiepartijen NIM TriVantage™ EMG endotracheale tubes ...

   Waarschuwing | 10-11-2023

9. Full Vision Inc, FSCA 20230519, Trackmaster Treadmills

   When given a start command from the integrated controller or attached stress system, the Drive and Motor is intended ...

   Waarschuwing | 10-11-2023

10. Fritz Stephan GmbH, FSN_QS.19-14357, Sophie

    Fritz Stephan GmbH is geinformeerd over een geval waarbij het meetmenu van een Sophie 2020 werd geopend zonder gebruikersinvoer. ...

    Waarschuwing | 02-11-2023