BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 24033840 · Received January 12, 2026

    Report

    Report Number
    3009529630-2026-100003
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    December 29, 2025
    Report Date
    March 26, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED, THE SYSTEM WAS NOT IN THE CLINICAL USE AT THE TIME OF EVENT OCCURRENCE. THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED FROM ERROR LOGS THAT THE IMAGE DISK WAS MALFUNCTIONING AND IDENTIFIED AS DEFECTIVE. THE FSE REPLACED THE IMAGE DISK TO RESOLVE THE ISSUE, RESTORING PROPER SYSTEM FUNCTIONALITY. AFTER REPLACEMENT, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. AT THE TIME THIS COMPLAINT WAS RECEIVED, PHILIPS DID NOT HAVE ENOUGH INFORMATION TO EXCLUDE THE POTENTIAL FOR DEATH OR SERIOUS INJURY ON RECURRENCE, AND AS SUCH THE COMPLAINT WAS REPORTED. SINCE THAT TIME, NEW INFORMATION HAS BEEN RECEIVED WHICH HAS LED TO THE DETERMINATION THAT THIS IS SCENARIO IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF IT WERE TO RECUR. AS PER THE INSTRUCTIONS FOR USE, THE USER OF THE PRODUCT MUST INSTITUTE A USER ROUTINE CHECKS PROGRAM. THE USER OF THE PRODUCT SHALL MAKE SURE THAT ALL CHECKS AND ACTIONS HAVE BEEN SATISFACTORILY COMPLETED BEFORE USING THE PRODUCT FOR ITS INTENDED PURPOSE. IT IS INSTRUCTED TO NOT USE THE PRODUCT FOR ANY APPLICATION UNTIL THE USER IS SURE THAT THE USER ROUTINE CHECKS HAVE BEEN SATISFACTORILY COMPLETED, THEREFORE, AS THE DEVICE WAS OUTSIDE OF USE AT THE TIME THE ISSUE WAS IDENTIFIED, THE USER WOULD IDENTIFY THIS ISSUE PRIOR TO USE. BASED ON RE-EVALUATION, THIS CASE IS NOT REPORTABLE. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE SYSTEM COULD NOT STORE IMAGES. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF EVENT. 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): K20091.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95823 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