BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 23411154 · Received October 29, 2025

    Report

    Report Number
    3003768277-2025-013294
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    October 9, 2025
    Report Date
    November 12, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    IZI
    UDI-DI
    00884838110564
    PMA / PMN Number
    K200917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS IDENTIFIED THAT THIS IS A DUPLICATE COMPLAINT FROM AN ALREADY REPORTED COMPLAINT. THE INVESTIGATION WILL BE ADDRESSED IN MFR REPORT NUMBER 3003768277-2025-012497. THIS COMPLAINT WILL BE CLOSED AS DUPLICATE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE SYSTEM DISPLAYED AN IMAGE DISK ISSUE MESSAGE AND COULD NOT STORE IMAGES. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO HARM TO THE PATIENT OR USER WAS REPORTED. 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
    2558277 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM IZI PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 5 M20 00884838110564

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown