BEUDAMED
    FDA Recall Terminated

    GE Inspection Technologies, LP - Phoenix v|tome|x m240 cabinet x-ray systems. A microfocus CT system used primarily for 3D metrology and analysis.

    Recall: Z-2236-2016 · Initiated March 2, 2016

    Recall

    Recall Number
    Z-2236-2016
    Event Number
    74554
    FEI Number
    2519904
    Product Code
    RCE
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    March 2, 2016
    Posted
    July 23, 2016
    Terminated
    August 7, 2017
    Address
    Rd, GE Inspection Technologies, LP 50 Industrial Park, Lewistown, PA, 17044-9312

    Description

    GE Inspection Technologies, LP - Phoenix v|tome|x m240 cabinet x-ray systems. A microfocus CT system used primarily for 3D metrology and analysis.

    Reason

    Radiation emissions which exceeded the limit in the performance standard were detected during maintenance of one system. The identified cause was insufficient attachment of shielding in the door. Jostling during delivery was identified as the probable cause of this failure to comply with the performance standard.

    Action

    GE plans to notify its customers with the systems through a TIL. The TIL will inform customers that GE will add lead strips to the inside window frame under the lead glass window of the main cabinet door. GE recommends that it visit each customer site and repair the system by adding lead strips along the window frame of the cabinet door, beneath the lead glass window, within 90 days following FDA's approval of the repair plan.

    Distribution

    US Distribution to the states of : FL, TN, and TX.

    Quantity

    4