BEUDAMED
    FDA Recall Terminated

    GE Healthcare Navigation Pin Transmitter (GE P/N 1004070) -Medical Systems InstaTrak Pin Transmitter

    Recall: Z-0709-06 · Initiated February 6, 2006

    Recall

    Recall Number
    Z-0709-06
    Event Number
    34730
    Firm
    GE OEC Medical Systems, Inc
    FEI Number
    1720753
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 6, 2006
    Posted
    April 7, 2006
    Terminated
    August 18, 2011
    Address
    384 Wright Brothers Dr, Salt Lake City, UT, 84116-2862

    Description

    GE Healthcare Navigation Pin Transmitter (GE P/N 1004070) -Medical Systems InstaTrak Pin Transmitter

    Reason

    Small retaining pin may detach and fall into the surgical field during stereotactic surgery.

    Action

    Consignees were notified by letter on 02/06/2006

    Distribution

    AL, AZ, CA, FL, GA, IL, IN, LA, MA, MD, MI, MN, MO, NJ, NV, NY, OR, PA, SC, TN, TX, UT, VA, WI, WV and one military facility in DC. Foreign distribution to Canada, Denmark, France Germany, Hong Kong, Italy, Japan, Switzerland, UK.

    Quantity

    186 units