BEUDAMED
    FDA Recall Terminated

    Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, Medtronic Navigation, Inc., Littleton, MA 01460 (software version 3.0)

    Recall: Z-0294-2008 · Initiated October 17, 2007

    Recall

    Recall Number
    Z-0294-2008
    Event Number
    45492
    Firm
    Medtronic Navigation, Inc
    FEI Number
    1000517638
    Product Code
    JZL
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    October 17, 2007
    Posted
    November 27, 2007
    Terminated
    November 27, 2007
    Address
    826 Coal Creek Circle, Louisville, CO, 80027-9710

    Description

    Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, Medtronic Navigation, Inc., Littleton, MA 01460 (software version 3.0)

    Reason

    Reversed Instrument Position : a defect in the software version 3.0 causes an error in the position of surgical instruments and relative motion are reversed 180' on the StealthStation image. (If the StealthStation is not used, or if the patient orientation is prone or supine, the problem does not occur)

    Action

    Medtronic Navigation notified customers by letter on October 17, 2007. Medtronic Field service will perform upgrade (software version 3.0.1) at user site.

    Distribution

    Worldwide: USA including states of CO, IN, NE, and MN and countries of Canada and Germany

    Quantity

    7 units