BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY CXDI-55G

    MDR report key: 2665210 · Received July 12, 2012

    Report

    Report Number
    1000181430-2012-00030
    Event Type
    Malfunction
    Date Received
    July 12, 2012
    Date of Event
    September 27, 2010
    Report Date
    July 9, 2012
    Manufacturer
    CANON INC.
    Product Code
    MQB
    PMA / PMN Number
    K091435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CANON INC. RELEASED A NEW FIRMWARE VERSION IN WHICH THE DEFECT IN QUESTION SHOULD HAVE BEEN CORRECTED.

    Description of Event or Problem · 1

    CANON U.S.A., INC. RECEIVED A REPORT THAT IMAGES OUTPUT BY TABS ARE EACH DISPLAYED WITH THIS BACKS AND FRONTS REVERSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIGITAL RADIOGRAPHY CXDI-55G SOLID STATE X-RAY IMAGER MQB CANON INC. CXDI-55G NA

    Patients

    Seq Age Sex Outcome Treatment
    1