Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. Philips Medizin Systeme Böblingen GmbH, FSCA 2023-CC-HPM-027, Patient Information Center iX

   Philips has become aware of a potential safety issue with the Patient Information Center (PIC iX) Release 4.x where Surveillances ...

   Waarschuwing | 14-09-2023

9. 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

10. Philips Medical Systems DMC GmbH, 2023-PD-DXR-009, Essenta DR Compact

    There is a potential cybersecurity issue with Essenta DR Compact Systems, which could result in unauthorized disclosure or ...

    Waarschuwing | 28-08-2023