BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 24727203 · Received March 30, 2026

    Report

    Report Number
    3009529630-2026-100021
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 18, 2026
    Report Date
    March 30, 2026
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838103276
    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 SYSTEM COULD NOT START UP. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF REPORTED EVENT. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT. THE COMPLAINT DEVICE AZURION 3 M15 (722280) IS NOT SOLD IN THE US. HOWEVER, ITS SIMILAR DEVICE 722222 IS MARKETED IN THE US UNDER 510(K): K200917.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789754 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 3 M15 00884838103276

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown