BEUDAMED
    FDA Recall Terminated

    GE Inspection Technologies x|tome|x L240 an Cabinet X-ray system

    Recall: Z-1211-2015 · Initiated January 13, 2015

    Recall

    Recall Number
    Z-1211-2015
    Event Number
    70478
    FEI Number
    2519904
    Product Code
    RCE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 13, 2015
    Posted
    March 20, 2015
    Terminated
    August 17, 2015
    Address
    Rd, GE Inspection Technologies, LP 50 Industrial Park, Lewistown, PA, 17044-9312

    Description

    GE Inspection Technologies x|tome|x L240 an Cabinet X-ray system

    Reason

    It was discovered that the upper left corner-shaped lead shield in the window in one of the doors of the v|tome|x L240 installed had lost adhesion and fall out of position, which could lead to gaps in shielding.

    Action

    GE Inspection Technologies, Planned Action: 1. GE will notify customers of the affected cabinet x-ray systems through a Technical Information Letter. GE notified its affected customers via email on January 13, 2015, via letter dated January 14, 2015, and via telephone on January 19, 2015. 2.GE will install an interim insert within 30 days of receipt of this letter. The insert will cover any existing or interim gaps in the original lead shielding on the door. 3. GE will replace the doors of affected cabinet x-ray systems no later than 180 day of receipt of this letter. 4. These corrections will be made free of charge. The Technical Information Letter used for notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter For further questions, please call (717) 447-1278

    Distribution

    US Distribution to the states of OH and PA.

    Quantity

    2