BEUDAMED
    FDA Enforcement Class II 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 · Reported October 19, 2016

    Enforcement

    Recall Number
    Z-0070-2017
    Event ID
    75279
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Navigation, Inc.-Littleton
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 19, 2016
    Initiation Date
    September 22, 2016
    Classification Date
    October 11, 2016
    Termination Date
    May 12, 2017
    Address
    300 Foster Street, N/A, Littleton, MA, 01460-2017, United States

    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

    Code Info

    Software revisions 4.0.0, 4.0.1 and 4.0.2. System Serial Numbers: C0930 C0981 C0986 C1113 C1069 C1050 C1208 C1043 C1144 C1163 C1145 C1162 C1002 C1074

    Distribution

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

    Quantity

    14 units