BEUDAMED
    FDA Recall Terminated

    Medtronic O-arm Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R.

    Recall: Z-2244-2012 · Initiated July 11, 2012

    Recall

    Recall Number
    Z-2244-2012
    Event Number
    62571
    Firm
    Medtronic Navigation, Inc.
    FEI Number
    3004785967
    Product Code
    OXO
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    July 11, 2012
    Posted
    August 22, 2012
    Terminated
    June 6, 2016
    Address
    300 Foster St, Littleton, MA, 01460-2017

    Description

    Medtronic O-arm Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R.

    Reason

    A fault in a high voltage relay in the 0-arm Imaging System might cause the relay to overheat and burn.

    Action

    Medtronic Navigation issued an "Urgent Field Safety Notice" to consignees dated 7/11/12. The problem was described and recommended actions were provided. For each affected O-arm Imaging System, a Medtronic service representative will visit the site and replace the 500VDC relay on the system and test the O-arm Imaging System.

    Distribution

    Worldwide Distribution - USA, including the states of AL, CO, FL, IA, MI, IA, NC, NE, NY and the countries of South Africa, Italy, and Spain.

    Quantity

    17 units