Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Respironics Inc_Philips FSCA 2021-07-A - Trilogy Evo, Trilogy Evo O2 and Trilogy EV300

   Er zijn twee softwareproblemen vastgesteld met betrekking tot druktoename. Het eerste probleem wordt omschreven als Druktoename ...

   Waarschuwing | 29-07-2021

2. The Spectranetics Corporation D055703 Bridge® Occlusion Balloon

   The Bridge Occlusion Balloon catheter is indicated for use for temporary vessel occlusion of the superior vena cava in ...

   Waarschuwing | 26-03-2020

3. PHILLIPS MEDICAL SYSTEMS, FSCA 2023-CC-HPM-022, Xper Flex Cardio Devices

   Following exposure to defibrillation voltage, the system returns to normal operating mode within 5 seconds. However, if the Xper ...

   Waarschuwing | 18-09-2023

4. Respironics California, LLC, FSN-FSCA 86600059-IR, V60 Ventilator/ V60 Plus Ventilator

   Er is een probleem geconstateerd in Philips V60-/V60 Plus-beademingsapparaten.

   Waarschuwing | 25-06-2021

5. Respironics, Inc., 2023-CC-SRC-039, BiPAP A30 Ventilator (Respironics, Inc.)

   Alle BiPAP A30-, BiPAP A30 EFL-, BiPAP A30 Hybrid-, BiPAP A40-, BiPAP A40 EFL-, BiPAP A40 Pro-apparaten Onderbrekingen en/of ...

   Waarschuwing | 15-04-2024

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. Elekta Ltd, FSN-FCA-EL-0012, Elekta Unity

   It has been reported that gradient cable connections have shown signs of excessive heating in the MRL Gradient Connection Module ...

   Waarschuwing | 06-05-2020

10. Xhale Assurance, Inc, FSCA-0001, Nasal Alar SpO2 Sensor

    An update has been made to the Xhale Assurance Nasal Alar SpO2 Sensor Instructions for Use (IFU) for revisions 10412_7 and prior ...

    Waarschuwing | 10-05-2019