BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIGITAL RADIOGRAPHY CXDI-55G

    MDR report key: 2896606 · Received December 31, 2012

    Report

    Report Number
    1000181430-2012-00160
    Event Type
    Other
    Date Received
    December 31, 2012
    Report Date
    July 11, 2011
    Manufacturer
    CANON, INC.
    Product Code
    MQB
    PMA / PMN Number
    K091435
    Removal / Correction Number
    Z-2265-2012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED RETROACTIVELY AS A RESULT OF AN INTERNAL AUDIT OF COMPLAINT FILES CONDUCTED BY CANON HEALTHCARE SOLUTIONS USA. (B)(4). THE PANEL WAS RETURNED AND WAS REPAIRED FOR THE LOOSE SCREW ISSUE. THE SERVICE ENGINEER PERFORMED CALIBRATION AND SELF TESTS. MANUFACTURER CROSS-REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WERE ARTIFACTS IN THE IMAGES. NO FURTHER INFORMATION WAS PROVIDED. IT IS POSSIBLE THAT THE IMAGE WAS RETAKEN, RESULTING IN UNINTENDED RADIATION EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIGITAL RADIOGRAPHY CXDI-55G MQB CANON, INC. CXDI-55G NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK