BEUDAMED
    FDA Enforcement Class II Terminated

    CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate, contained in an X-Ray cassette, used to capture images from X-Ray exposures. The cassette with the image plate, once exposed, is inserted in the Agfa Digitizer CR 10-X where the image plate is taken out of the cassette and then scanned so that the scanned image can be displayed for viewing.

    Recall: Z-0970-2013 · Reported March 27, 2013

    Enforcement

    Recall Number
    Z-0970-2013
    Event ID
    64529
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    AGFA Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    March 27, 2013
    Initiation Date
    February 7, 2013
    Classification Date
    March 18, 2013
    Termination Date
    June 6, 2013
    Address
    10 S Academy St, N/A, Greenville, SC, 29601-2632, United States

    Description

    CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate, contained in an X-Ray cassette, used to capture images from X-Ray exposures. The cassette with the image plate, once exposed, is inserted in the Agfa Digitizer CR 10-X where the image plate is taken out of the cassette and then scanned so that the scanned image can be displayed for viewing.

    Reason

    The cassettes were shipped with the wrong IP (image plate) size bar code.

    Code Info

    Batch No. A2KQMW

    Distribution

    USA Nationwide Distribution including the states of: AL, CA, FL, IN, MN, NE, NV, OH, SC and UT.

    Quantity

    17