BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 22978134 · Received September 5, 2025

    Report

    Report Number
    3003768277-2025-009121
    Event Type
    Malfunction
    Date Received
    September 5, 2025
    Date of Event
    August 11, 2025
    Report Date
    October 16, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    PMA / PMN Number
    K162859
    Removal / Correction Number
    Z-1156-2024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS INVESTIGATED THIS COMPLAINT. THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ON-SITE AND CONFIRMED THAT THE SYSTEM WAS HANGING, PREVENTING A FULL SYSTEM BOOT-UP. UPON TROUBLESHOOTING, THE FSE CHECKED THE SYSTEM AND FOUND AN IPPC MEMORY ERROR DURING THE BOOTUP. UPON FURTHER ANALYSIS, THE FSE REVIEWED THE LOGS AND IDENTIFIED THAT IT WAS AN IPPC MEMORY ERROR. TO RESOLVE THE ISSUE, THE FSE CLEANED AND RESEATED ALL MEMORY CARDS IN THE IPPC. DUE TO MANUFACTURING ISSUES, THE DIMMS (DUAL IN-LINE MEMORY MODULES) MAY NOT FUNCTION AS INTENDED, LEADING TO ISSUES WITH THE ALLURA XPER AND ALLURA CENTRON SYSTEM'S IMAGING PROCESSING PC, HOST PC, AND FLEX VISION PC. IF ONE OF THESE PCS BREAKS DOWN, THE SYSTEM STOPS FUNCTIONING, AND NO IMAGING IS POSSIBLE. PHILIPS HAS INITIATED A MEDICAL DEVICE CORRECTION Z-1156-2024. AFTER THAT, THE SYSTEM WAS 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 HANGING, PREVENTING A FULL SYSTEM BOOT. THE DEVICE WAS OUTSIDE OF CLINICAL USE AT THE TIME OF THE 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
    1975691 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