BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 23134456 · Received September 24, 2025

    Report

    Report Number
    3003768277-2025-010942
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    November 15, 2021
    Report Date
    September 24, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    PMA / PMN Number
    K162859
    Removal / Correction Number
    C&R#: 3003768277-06/23/2
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS SUBMITTED IN AGREEMENT WITH FDA FOR THE RETROSPECTIVE REPORTING COMMITMENT (REFERENCE: (B)(4)) AND IS RELATED TO AND OCCURRED PRIOR TO (C&R#: 3003768277-06/23/2023-004-C).

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT WIRELESS FOOTSWITCH ISSUE. THIS IS CONNECTED TO LOSS OF IMAGE RELATED TO A ALLURA XPER FD20. THERE WAS NO REPORTED PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2492999 ALLURA XPER FD INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown