Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Philips Medical Systems Nederland BV, 2023-IGT-BST-024, Philips Azurion 7 M20 FlexArm system with Maquet M

   If, during a procedure, the detector is positioned at a distance of approximately four (4) cm from the patient, the connection ...

   Waarschuwing | 15-12-2023

2. Philips Medical Systems Nederland BV, 2023-IGT-BST-005, Philips Azurion

   Philips has identified a potential issue which can cause the system to continuously restart (restart loop). This is likely to ...

   Waarschuwing | 15-12-2023

3. Philips Medical Systems Nederland B.V., 2023-PD-CTAMI-010, Spectral CT 7500

   Philips has identified multiple software issues affecting Spectral CT 7500 systems. The detailed descriptions of these issues are ...

   Waarschuwing | 14-12-2023

4. Philips Medical Systems, FSCA 2023-CC-HPM-046, CareEvent

   It has been discovered that background notifications for the Care Assist application fail to send from PIC iX Event Notification ...

   Waarschuwing | 12-12-2023

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. Philips Medical Systems Nederland B.V., 2023-PD-CTAMI-015, Brilliance CT Big Bore; Philips CT Big Bore

   Na het uitvoeren van een niet-gecentreerde reconstructie en het verzenden van de beeldgegevens naar andere TPS-werkstations ...

   Waarschuwing | 01-12-2023

7. Philips Healthcare, 2023-PD-MR-020, Panorama 1.0T HFO

   Tijdens een quench verdampt een grote hoeveelheid helium en dit wordt via een ventilatiekanaal afgevoerd naar buiten het gebouw. ...

   Waarschuwing | 28-11-2023

8. Philips Healthcare, 2023-PD-MR-014, Philips Intera, Achieva, Ingenia CX

   Fabrikant: Philips Healthcare Product: Philips Intera, Achieva, Ingenia CX Datum FSN: 7-11-2023 Waarschuwing van fabrikant Dit ...

   Waarschuwing | 10-11-2023

9. Philips Goldway (Shenzhen) Industrial Inc., 2023-CC-EC-026-IR, Philips HeartStart Intrepid Monitor/Defibrillator

   The current HeartStart Intrepid Service Manual does not detail IEC Class I electrical safety test verification methods. The lack ...

   Waarschuwing | 02-11-2023

10. Philips Medical Systems Nederland BV, 2023-IGT-BST-004, Philips Allura Xper, Azurion and MultiDiagnost -El and MD Eleva systems

    The wired foot switch is used to control fluoroscopy, exposure, and other functions, such as single shot, light control, and ...

    Waarschuwing | 27-09-2023