BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VUE PACS

    MDR report key: 23846161 · Received December 18, 2025

    Report

    Report Number
    3003768277-2025-015812
    Event Type
    Malfunction
    Date Received
    December 18, 2025
    Date of Event
    April 23, 2024
    Report Date
    December 18, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    LLZ
    UDI-DI
    00884838100343
    PMA / PMN Number
    K170580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON 21-NOVEMBER-2025 PHILIPS RECEIVED A REQUEST OF INFORMATION ON IMAGES THAT WERE MISSING SINCE EARLY 2024 ON VUE PACS. NO PATIENT HARM, DEATH, SERIOUS INJURIES HAVE BEEN REPORTED THE RISK ASSESSMENT HAS BEEN PERFORMED INDICATING THAT THIS ISSUE WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THIS WERE TO RECUR, HOWEVER PHILIPS REPORT THIS DATA LOSS ISSUE AS A CONSERVATIVE RISK BASE APPROACH. TECHNICAL INVESTIGATION INDICATES THAT STUDIES WERE DELETED FROM SATELLITE PACS AS THEY WERE CONSIDERED AS BACKED-UP TO DATA CENTER, ALTHOUGH THEY WERE NOT BACKED-UP. THE ISSUE WAS IDENTIFIED WHILE THE CUSTOMER TRIED TO BURN A STUDY ON CD. THIS OCCURRED BECAUSE THE STUDIES WERE LINKED TO A ¿DUMMY¿ DC LOCATION, WHICH CAUSED THE AUTODELETE MECHANISM TO REMOVE THEM UNDER THE ASSUMPTION THAT THEY HAD BEEN SUCCESSFULLY BACKED UP TO THE DC. IN REALITY, THESE LOCATIONS WERE CONSIDERED ¿DUMMY¿ BECAUSE THE STUDIES WERE NEVER COPIED TO THE DC. THE MISSING IMAGES CANNOT BE RECOVERED; HOWEVER, THE CORRESPONDING REPORTS REMAIN AVAILABLE. ALL SYSTEMS WITHIN THE CUSTOMER NETWORK WERE REVIEWED TO VERIFY THAT NO ¿DUMMY¿ LOCATIONS EXIST THAT COULD CAUSE THE SYSTEM TO ERRONEOUSLY TRIGGER AN AUTOMATED DELETION OPERATION.

    Description of Event or Problem · 0

    MRI AND XRAY IMAGES OF PATIENT (B)(6) NOT TRANSFERRING TO CD BURNER FROM VUE PACS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2243130 VUE PACS SYSTEM, IMAGE PROCESSING, RADIOLOGICAL LLZ PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VUE PACS 00884838100343

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other