BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KALARE DIAGNOSTIC X-RAY SYSTEM KXO-80XD

    MDR report key: 3443816 · Received October 29, 2013

    Report

    Report Number
    MW5032488
    Event Type
    Injury
    Date Received
    October 29, 2013
    Date of Event
    October 24, 2013
    Report Date
    October 28, 2013
    Manufacturer
    TOSHIBA
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TABLE X-RAY TUBE FAILED AFTER 22 MONTHS OF USE IN TOSHIBA KALARE DIAGNOSTIC RF X-RAY SYSTEM. THE RECALL ISSUED IN APRIL 2013 STATES THAT WHEN CONDITIONS WITH THE SMALL FOCAL SPOT ARE SET AND THE READY SWITCH IS HELD DOWN, THE LARGE FOCAL SPOT IS ALSO HEATED, AS A RESULT THE TUBE CURRENT EXCEEDING THE SET VALUE FLOWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554252 KALARE DIAGNOSTIC X-RAY SYSTEM KXO-80XD KALARE DIAGNOSTIC X-RAY SYSTEM KXO-80XD JAA TOSHIBA KXO-80XD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention