BEUDAMED
    FDA Enforcement Class II Terminated

    DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities, check abdomen and other both parts.

    Recall: Z-2175-2014 · Reported August 20, 2014

    Enforcement

    Recall Number
    Z-2175-2014
    Event ID
    68752
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    AGFA Healthcare Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 20, 2014
    Initiation Date
    July 2, 2014
    Classification Date
    August 9, 2014
    Termination Date
    June 4, 2015
    Address
    10 S Academy St, N/A, Greenville, SC, 29601-2632, United States

    Description

    DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities, check abdomen and other both parts.

    Reason

    Some customers reported that while using the DX-D600 in room or exam preparation, the Overhead Tube Crane (OTC) showed increased velocity and uncontrolled longitudinal movement.

    Code Info

    Serial Nos. A5430000089, A5430000131, A5430000015, A5430000095, A5430000052, A5430000061, A5430000079, A5430000030, A5430000042, A5430000066, A5430000081, A5430000085, A5430000096, A5430000020, A5430000067, A5430000125, A5430000105

    Distribution

    Worldwide Distribution - US Natinwide in the state of GA, IN, KS, KY, MA, NJ, SC, VA, DC and the country of Canada

    Quantity

    17 units