BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 24774325 · Received April 3, 2026

    Report

    Report Number
    3009529630-2026-100023
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    March 21, 2026
    Report Date
    April 3, 2026
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838110564
    PMA / PMN Number
    K200917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE IMAGES COULD NOT BE SEEN. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT. THE COMPLAINT DEVICE AZURION 5 M20 (722281) IS NOT SOLD IN THE US. HOWEVER, ITS SIMILAR DEVICE 722228 IS MARKETED IN THE US UNDER 510(K): K200917.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6441 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 5 M20 00884838110564

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown