BEUDAMED
    FDA Enforcement Class II Terminated

    Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

    Recall: Z-2313-2016 · Reported August 10, 2016

    Enforcement

    Recall Number
    Z-2313-2016
    Event ID
    74715
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Navigation, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 10, 2016
    Initiation Date
    July 18, 2016
    Classification Date
    August 2, 2016
    Termination Date
    December 1, 2016
    Address
    826 Coal Creek Cir, Louisville, CO, 80027-9710, United States

    Description

    Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

    Reason

    Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.

    Code Info

    Model Number 9733763. All lot numbers manufactured by Medtronic Navigation are affected.

    Distribution

    Worldwide Distribution - US Nationwide in the state of: NY, AZ, AR, NC, CA, OH, MI, IN, MA, TX, OH, OR, CO, MO, UT, IL. and the countries of: India, Australia, and Russian Federation.

    Quantity

    27 in total