BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 23791077 · Received December 12, 2025

    Report

    Report Number
    3003768277-2025-015710
    Event Type
    Malfunction
    Date Received
    December 12, 2025
    Date of Event
    December 8, 2025
    Report Date
    March 13, 2026
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    IZI
    UDI-DI
    00884838059054
    PMA / PMN Number
    K130842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT UP. UPON TROUBLESHOOTING, THE PHILIPS REMOTE SERVICE ENGINEER (RSE) CHECKED THE SYSTEM REMOTELY AND CUSTOMER INFORMED THAT THE SYSTEM DID NOT FULLY POWER ON FOR USE ON THE MORNING. THE RSE FOUND A BLOWN FUSE IN THE M CABINET, AND IT WAS OBSERVED THAT THE IMAGE PC WAS NOT POWERED ON AT THAT TIME. THE RSE REPLACED THE FUSE IN THE POWER SUPPLY, BUT IT BLEW AGAIN. THE FIELD SERVICE ENGINEER INSPECTED THE FLEX VISION PC AND IPPC ON SITE AND FOUND THE PC WAS NOT POWERED. CABINET POWER WAS CONFIRMED AT 230 V, AND FURTHER CHECKS REVEALED THE IPPC HAD NO INTERNAL POWER DUE TO A FAULTY POWER MODULE. TO RESOLVE THE ISSUE, THE FSE REPLACED THE IPPC AND REINSTALLED THE ORIGINAL HARD DRIVE. THE DEFECTIVE PART WAS SENT FOR ANALYSIS, FOR IPPC, FAILURE WAS OBSERVED AND THE FAILURE WAS FAILED POWER SUPPLY. AFTER REPLACEMENT, THE SYSTEM RETURNED TO USE IN GOOD WORKING ORDER. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT UP. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME OF REPORTED EVENT. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2702612 ALLURA XPER FD SYSTEM, X-RAY, ANGIOGRAPHIC IZI PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20 00884838059054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown