BEUDAMED
    FDA Recall Terminated

    Stealth Station Cranial Application v.4.5

    Recall: Z-0711-05 · Initiated January 28, 2005

    Recall

    Recall Number
    Z-0711-05
    Event Number
    31133
    Firm
    Medtronic Surgical Navigation Technologies, Inc
    FEI Number
    1000517638
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 28, 2005
    Posted
    April 16, 2005
    Terminated
    April 15, 2005
    Address
    826 Coal Creek Cir, Louisville, CO, 80027-9710

    Description

    Stealth Station Cranial Application v.4.5

    Reason

    The Stealth Station Cranial Application Version 4.5 contains a software anomaly, which may present a hazard to the patient.

    Action

    Customers were sent notification letters dated 01/28/05 and 02/02/05.

    Distribution

    Domestic distribution: FL, CO, AZ, TX, AR, MT, OK, IL, PA, NY, LA, WI, NC, ND, CA, GA, AL, OR, WY, WA, OH, NV. Foreign distribution: Belgium, Czech Republic, China (Malaysia). No military or VA facilites.

    Quantity

    53 systems with software version 4.5