BEUDAMED
    FDA Recall Terminated

    Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 Product Usage: The O-arm Surgical Imaging System is a multi-dimensional surgical imaging platform that is designed for use in spine, orthopaedic, and trauma-related surgeries. It provides real-time, intra-operative imaging of a patients anatomy with high quality images and a large field-of-view in both two and three dimensions

    Recall: Z-0070-2017 · Initiated September 22, 2016

    Recall

    Recall Number
    Z-0070-2017
    Event Number
    75279
    Firm
    Medtronic Navigation, Inc.-Littleton
    FEI Number
    3004785967
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 22, 2016
    Posted
    October 11, 2016
    Terminated
    May 12, 2017
    Address
    300 Foster Street, Littleton, MA, 01460-2017

    Description

    Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 Product Usage: The O-arm Surgical Imaging System is a multi-dimensional surgical imaging platform that is designed for use in spine, orthopaedic, and trauma-related surgeries. It provides real-time, intra-operative imaging of a patients anatomy with high quality images and a large field-of-view in both two and three dimensions

    Reason

    O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images

    Action

    Medtronic Navigation contacted customers via telephone beginning September 23, 2016. Customers were informed of the affected product, problem and actions to be taken. Medtronic requests that users immediately discontinue the use of the O-Arm O2 Surgical Imaging system for automatic registration in Stealth Station navigated surgical procedures until further notice. Medtronic Service personnel have been scheduled to begin the necessary inspections and re-calibration activities on customer systems beginning on September 23, 2016.

    Distribution

    Worldwide Distribution - US Nationwide in the states of CO, KA, NE, MI, MO, OH, WA and country of Switzerland

    Quantity

    14 units