BEUDAMED
    FDA Enforcement Class II Terminated

    Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXDI-55G and CXDI-70C. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.

    Recall: Z-2265-2012 · Reported September 5, 2012

    Enforcement

    Recall Number
    Z-2265-2012
    Event ID
    62828
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Canon Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    September 5, 2012
    Initiation Date
    November 1, 2010
    Classification Date
    August 24, 2012
    Termination Date
    January 7, 2014
    Address
    30-2, Shimomaruko 3-chome,, Ohta-ku, Tokyo, N/A, N/A, Japan

    Description

    Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXDI-55G and CXDI-70C. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.

    Reason

    Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor.

    Code Info

    Catalog numbers 3930B002AA, 3928B002AA, and 4066B002AA.

    Distribution

    Nationwide Distribution (USA)

    Quantity

    468 units