BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 24033701 · Received January 12, 2026

    Report

    Report Number
    3009529630-2026-100002
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    December 25, 2025
    Report Date
    May 14, 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
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT INTERMITTENTLY THE SYSTEM GEOMETRY MOVEMENTS WERE UNAVAILABLE. 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
    407336 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 3 M15 00884838103276

    Patients

    Seq Age Sex Outcome Treatment
    1