BEUDAMED
    FDA Recall Terminated

    Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The O-arm O2 Imaging System is compatible with certain image guided surgery systems.

    Recall: Z-1088-2016 · Initiated January 29, 2016

    Recall

    Recall Number
    Z-1088-2016
    Event Number
    73303
    Firm
    Medtronic Navigation, Inc.
    FEI Number
    3004785967
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 29, 2016
    Posted
    March 8, 2016
    Terminated
    March 10, 2016
    Address
    300 Foster St, Littleton, MA, 01460-2017

    Description

    Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The O-arm O2 Imaging System is compatible with certain image guided surgery systems.

    Reason

    Screws holding the detector panel in as a result the detector panel could make contact with other parts with in the 0-arm 02 Imaging System, causing noise and vibration when being positioned or during 3D Imaging could lead to poor image quality

    Action

    Medtronic Navigation issued a Field Safety Notice dated January 29, 2016, to notify them of a hardware correction in the unit. A Medtronic service representative will service the system and arrange for an inspection of the system. This representative will properly torque the eight (8) screws if they find them to be loose. In the meantime, if noise or vibration are observed during use of the system customers should contact their Medtronic representative to report the issue. Customers with questions were instructed to call 720-890-3160. For questions regarding this recall call 978-698-6000.

    Distribution

    Worldwide Distribution to Austria only.

    Quantity

    1 unit