BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD10

    MDR report key: 23449857 · Received November 3, 2025

    Report

    Report Number
    3003768277-2025-013764
    Event Type
    Malfunction
    Date Received
    November 3, 2025
    Date of Event
    October 18, 2021
    Report Date
    November 3, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    IZI
    PMA / PMN Number
    K041949
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS SERVICE REPLACED THE CONVERTER 1, KV-MA UNIT, TUBE, FLEX-PC, AND CONVERTER 2, AND RETURNED THE DEVICE TO USE. THIS REPORT WAS SUBMITTED IN AGREEMENT WITH FDA FOR THE RETROSPECTIVE REPORTING COMMITMENT (REFERENCE: (B)(4)).

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE IMAGE WAS BLACK DUE TO HIGH KV ILLUMINATION ERROR ON A ALLURA XPER FD10. THE CLINICAL USE OF THE SYSTEM WAS IN USE. THERE WAS NO REPORTED PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053454 ALLURA XPER FD10 SYSTEM, X-RAY, ANGIOGRAPHIC IZI PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown