BEUDAMED
    FDA Recall Terminated

    InstaTrak 3500 Plus system with cranial application (aid to the surgeon for locating anatomical structures in the human body)

    Recall: Z-0704-2007 · Initiated January 26, 2005

    Recall

    Recall Number
    Z-0704-2007
    Event Number
    31058
    Firm
    GE OEC Medical Systems, Inc
    FEI Number
    1720753
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 26, 2005
    Posted
    March 30, 2007
    Terminated
    July 8, 2011
    Address
    384 Wright Brothers Dr, Salt Lake City, UT, 84116-2862

    Description

    InstaTrak 3500 Plus system with cranial application (aid to the surgeon for locating anatomical structures in the human body)

    Reason

    Tracking inaccuracy of 5-10 mm may result when the shunt guide accessory is used with version 5.1 software.

    Action

    Consignees were visited by GE personnel to upgrade the software, beginning in April, 2004, to version 5.2

    Distribution

    Worldwide distribution --- USA including states of AK, AZ, AL, CA, CT, IA, IL, MD, ME, MO, MT, MS, NC, NJ, NY, OH, PA, RI, SD, UT, TX, VA, WA and WI and countries of France, United Kingdom, Japan, Italy, India and Canada

    Quantity

    91 systems (version 5.1 software)