BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 21974221 · Received May 7, 2025

    Report

    Report Number
    3003768277-2025-004152
    Event Type
    Malfunction
    Date Received
    May 7, 2025
    Date of Event
    April 23, 2025
    Report Date
    April 24, 2026
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    IZI
    UDI-DI
    00884838059030
    PMA / PMN Number
    K130842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT AND IDENTIFIED THAT IT IS A DUPLICATE OF AN ALREADY REPORTED COMPLAINT (3003768277-2025-002795 / TW (B)(4)). THE INVESTIGATION HAS BEEN CARRIED OUT VIA 3003768277-2025-002795 (TW (B)(4). THIS COMPLAINT WILL BE CLOSED AS DUPLICATE. THE FDA ESTABLISHMENT REGISTRATION NUMBER [FEI] HAS BEEN UPDATED AND REPORTED TO THE FDA, CHANGING FROM 3003768277 TO 3042175844, EFFECTIVE DECEMBER 21, 2025. THIS CHANGE REFLECTS AS ADMINISTRATIVE REGISTRATION UPDATE ONLY. THERE HAVE BEEN NO CHANGES TO THE REGISTERED OWNER/OPERATOR, OFFICIAL CORRESPONDENT, LEGAL ENTITY NAME, PHYSICAL ESTABLISHMENT ADDRESS, MANUFACTURING PROCESSES, OR TO THE DESIGN, SPECIFICATIONS, INTENDED USE, OR MANUFACTURING PROCESSES OF ANY LISTED DEVICES.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE GEOMETRY MODULE JOYSTICK WAS NOT WORKING, WHICH COULD IMPACT GEOMETRY MOVEMENTS. 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
    494744 ALLURA XPER FD SYSTEM X-RAY ANGIOGRAPHIC IZI PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10 00884838059030

    Patients

    Seq Age Sex Outcome Treatment
    1