BEUDAMED
    FDA Recall Terminated

    StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures.

    Recall: Z-1956-2013 · Initiated July 15, 2013

    Recall

    Recall Number
    Z-1956-2013
    Event Number
    65743
    Firm
    Medtronic Navigation, Inc.
    FEI Number
    1000517638
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 15, 2013
    Posted
    August 13, 2013
    Terminated
    January 29, 2014
    Address
    826 Coal Creek Cir, Louisville, CO, 80027-9710

    Description

    StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures.

    Reason

    Medtronic Navigation, Inc. has initiated a field correction to their Framelink software version 5.4 which can be used on Medtronic Navigation StealthStation 57 and i7 systems or a Medtronic Planning Station due to the potential of discrepancy between the exam image and the displayed measurement or overlay under certain conditions of use.

    Action

    A Field Safety Notice was sent on 7/15/13 to users informing them that the Framelink software version 5.4 has been revised to correct the software anomalies described in this letter. A new version will be installed on their system(s) by a Medtronic Navigation representative. Until the software upgrade has been installed on their system, do not use high resolution examinations (greater than 256 x 256). If users are not sure of the exam resolution being used, firm recommend contacting the hospital imaging department or local Medtronic Navigation representative for assistance. Medtronic representatives will visit all identified hospitals and upgrade all systems to version 5.4.1. This will account for all consignees.

    Distribution

    Worldwide Distribution.

    Quantity

    572