BEUDAMED
    FDA Recall Terminated

    Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile

    Recall: Z-0926-2013 · Initiated January 31, 2013

    Recall

    Recall Number
    Z-0926-2013
    Event Number
    64256
    Firm
    Medtronic Navigation, Inc.
    FEI Number
    3004785967
    Product Code
    OXO
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    January 31, 2013
    Posted
    March 8, 2013
    Terminated
    July 6, 2016
    Address
    300 Foster St, Littleton, MA, 01460-2017

    Description

    Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile

    Reason

    Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction

    Action

    Medtronic Navigation issued a Field Safety Notice letter dated January 18, 2013 to all affected customers. The letter identified the affected product, problem, and actions to be taken. The letter instructed customers not to discontinue use and that a Medtronic Navigation Representative will be contacting them shortly to schedule a time to conduct the motion control box upgrade. For questions contact your local Medtronic Navigation representative or call Technical Services Group at 800-595-9709 or (720) 890-3200, or email at rs.navtechsupport@ medtronic.com.

    Distribution

    Worldwide Distribution - USA Nationwide and the countries of: Canada, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CHILE, CHINA, CROATIA, CZECH REPUBLIC, DENMARK,FINLAND, FRANCE, GERMANY, GREECE, INDIA, IRELAND, ISRAEL, ITALY, JAPAN ,KOREA, REPUBLIC OF KUWAIT, LEBANON, LIBYAN ARAB JAMAHIRIYA, MEXICO, NETHERLANDS, New Zealand, POLAND, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, Taiwan(R.O.C.) , THAILAND, TURKEY, UNITED ARAB EMIRATES. and UNITED KINGDOM.

    Quantity

    463 units