BEUDAMED
    FDA Enforcement Class II Terminated

    GE Inspection Technologies x|argos 160D system. Cabinet x-ray system.

    Recall: Z-1225-2015 · Reported April 1, 2015

    Enforcement

    Recall Number
    Z-1225-2015
    Event ID
    70478
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Inspection Technologies, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 1, 2015
    Initiation Date
    January 13, 2015
    Classification Date
    March 20, 2015
    Termination Date
    August 17, 2015
    Address
    50 Industrial Park Rd, Lewistown, PA, 17044-9312, United States

    Description

    GE Inspection Technologies x|argos 160D system. Cabinet x-ray system.

    Reason

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

    Code Info

    SN - PA1053

    Distribution

    US Distribution to the states of OH and PA.

    Quantity

    2