BEUDAMED
    FDA Recall Terminated

    Polaris Spectra System Control Unit, a component of the StealthStation S7 System. Medtronic Navigation, Louisville, CO 80027. Intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures.

    Recall: Z-0715-2011 · Initiated November 5, 2010

    Recall

    Recall Number
    Z-0715-2011
    Event Number
    57277
    Firm
    Medtronic Navigation, Inc
    FEI Number
    1000517638
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    November 5, 2010
    Posted
    December 17, 2010
    Terminated
    May 3, 2011
    Address
    826 Coal Creek Circle, Louisville, CO, 80027-9710

    Description

    Polaris Spectra System Control Unit, a component of the StealthStation S7 System. Medtronic Navigation, Louisville, CO 80027. Intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures.

    Reason

    Electronic surgical navigation aid may lose tracking ability or stop working.

    Action

    Customers were notified by a Product Correction Notification letter on 11/05/2010. The letter advised customers of the affected product, the potential problem, and the description of the correction. Customers were told that a Medtronic rep will visit them to install a replacement control unit. Further information is available at 800-595-9709 or 720-890-3200.

    Distribution

    Worldwide Distribution -- US, including states of AL, AZ, CO, FL, GA, KY, MD, MN, NE, PA, TX, WI, and MD and countries of Australia, Belgium, Canada, Czech Republic, Italy, Netherlands, Poland, Portugal, Saudi Arabia, Singapore, South Korea, Spain, Turkey, and UAE.

    Quantity

    48 devices