BEUDAMED
    FDA Enforcement Class II Terminated

    OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical structures during open percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MRI, or X-ray.

    Recall: Z-2236-2012 · Reported August 29, 2012

    Enforcement

    Recall Number
    Z-2236-2012
    Event ID
    62744
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE OEC Medical Systems, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 29, 2012
    Initiation Date
    October 11, 2006
    Classification Date
    August 21, 2012
    Termination Date
    August 22, 2012
    Address
    384 Wright Brothers Dr, N/A, Salt Lake City, UT, 84116-2862, United States

    Description

    OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical structures during open percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MRI, or X-ray.

    Reason

    GE Healthcare had recalled certain OEC InstaTrak 3500 Carts due to the potential for the cart to tip over when the arm of the imaging device is extended during use.

    Code Info

    Model number A857680 with various serial numbers (refer to consignee list).

    Distribution

    Nationwide Distribution.

    Quantity

    99 units