BEUDAMED
    FDA Recall Terminated

    Polaris Spectra Position Sensor Unit, a component of the StealthStation S7 System, Medtronic Navigation, Louisville, CO 80027. The Polaris Spectra Position Sensor Unit (PSU) is the component of the StealthStation S7 System which detects optical markers on instruments and reference frames, determines their spatial positions, and continuously reports this information to the system computer. The computer uses this spatial information, in conjunction with information regarding the geometry of the instrument currently in use, to determine where the tip of the instrument is located on the patient anatomy.

    Recall: Z-1558-2011 · Initiated December 22, 2010

    Recall

    Recall Number
    Z-1558-2011
    Event Number
    57696
    Firm
    Medtronic Navigation, Inc
    FEI Number
    1000517638
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    December 22, 2010
    Posted
    March 4, 2011
    Terminated
    March 11, 2011
    Address
    826 Coal Creek Circle, Louisville, CO, 80027-9710

    Description

    Polaris Spectra Position Sensor Unit, a component of the StealthStation S7 System, Medtronic Navigation, Louisville, CO 80027. The Polaris Spectra Position Sensor Unit (PSU) is the component of the StealthStation S7 System which detects optical markers on instruments and reference frames, determines their spatial positions, and continuously reports this information to the system computer. The computer uses this spatial information, in conjunction with information regarding the geometry of the instrument currently in use, to determine where the tip of the instrument is located on the patient anatomy.

    Reason

    Position Sensor Unit may generate tracking errors or may stop tracking immediately.

    Action

    The firm, Medtronic, sent a "Product Correction Notification" letter dated December 22, 2010, to all US Consignees/Customers on December 23, 2010 and foreign Consignees/Customers on December 27, 2010. The letter described the product, problem and actions to be taken. The customer were instructed to discontinue use of the impacted navigation system(s) until a replacement camera (PSU) is installed. A Medtronic Navigation Representative will visit each facility to remove the navigation camera and install a replacement. If you have any questions, contact your Medtronic Navigation Representative or Medtronic Navigation Technical Support services at 1-800-595-9709 or +1-720-890-3200.

    Distribution

    Worldwide distribution: USA including states of: CA, CO, GA, SC, TN, and WI; and countries including: Australia, Canada, Chile, Russia, Saudi Arabia, and South Africa.

    Quantity

    11 (US), 8 (Intnl)