BEUDAMED
    FDA Enforcement Class II 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 · Reported August 21, 2013

    Enforcement

    Recall Number
    Z-1956-2013
    Event ID
    65743
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Navigation, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 21, 2013
    Initiation Date
    July 15, 2013
    Classification Date
    August 13, 2013
    Termination Date
    January 29, 2014
    Address
    826 Coal Creek Cir, Louisville, CO, 80027-9710, United States

    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.

    Code Info

    Lot number(s): Not applicable; All kits containing the Framelink Software version 5.4 are affected by this corrective action.

    Distribution

    Worldwide Distribution.

    Quantity

    572