BEUDAMED
    FDA Recall Terminated

    Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging.

    Recall: Z-1849-2012 · Initiated October 12, 2010

    Recall

    Recall Number
    Z-1849-2012
    Event Number
    61741
    Firm
    Medtronic Navigation, Inc.
    FEI Number
    3004785967
    Product Code
    IZL
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 12, 2010
    Posted
    June 21, 2012
    Terminated
    June 21, 2012
    Address
    300 Foster St, Littleton, MA, 01460-2017

    Description

    Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging.

    Reason

    Software Version 3.1.1 does not meet navigational accuracy.

    Action

    Medtronic Navigation contacted customers by telephone on 10/12/2010 and with "Urgent Field Safety Notice" follow up letters dated 10/14 or 10/15/2010. Sites were visited by Medtronic Service Representative to complete navigational accuracy testing and either replace or correct the unit.

    Distribution

    Nationwide Distribution including the states of CO, IN, and MN.

    Quantity

    3 units