BEUDAMED
    FDA Recall Terminated

    GE OEC, Insta Trak 3500 Plus with the Cranial Application for Image Guided Surgery, GE Healthcare, Surgery, Salt Lake City, UT 84116

    Recall: Z-0183-2008 · Initiated October 18, 2007

    Recall

    Recall Number
    Z-0183-2008
    Event Number
    45441
    Firm
    GE OEC Medical Systems, Inc
    FEI Number
    1720753
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 18, 2007
    Posted
    January 23, 2008
    Terminated
    August 10, 2012
    Address
    384 Wright Brothers Dr, Salt Lake City, UT, 84116-2862

    Description

    GE OEC, Insta Trak 3500 Plus with the Cranial Application for Image Guided Surgery, GE Healthcare, Surgery, Salt Lake City, UT 84116

    Reason

    Crack, Fracture or Detachment: The Transmitter Arm for the Mayfield-compatible Transmitter may become detached from the unit and enter into the surgical field.

    Action

    Consignees were sent an Urgent Recall Notice via mail dated 10/11/07, notifying the customer to examine the plastic end of the transmitter arm and to not use the transmitter arm, if any cracks or damage are observed. Also to stop using Steam Sterilization method and to utilize the other Sterilization methods indicated in the Operators Manual. The root cause is still under investigation GEHC Surgery will provide, at no charge, a solution to this issue when it becomes available.

    Distribution

    Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IL, MA, MD, MI, MS, NC, NY, OK, OR, PA, SC, TX, UT, VA, WI, and WV, and countries of Canada, China, France, Hong Kong, Japan, Mexico, Spain, and Switzerland.

    Quantity

    169 units