BEUDAMED
    FDA Recall Terminated

    Medtronic O-Arm Intraoperative Imaging System Catalog Number: BI-700-00027

    Recall: Z-0624-2009 · Initiated November 27, 2007

    Recall

    Recall Number
    Z-0624-2009
    Event Number
    45967
    Firm
    Medtronic Navigation, Inc
    FEI Number
    1000517638
    Product Code
    IZL
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 27, 2007
    Posted
    February 4, 2009
    Terminated
    January 22, 2016
    Address
    826 Coal Creek Circle, Louisville, CO, 80027-9710

    Description

    Medtronic O-Arm Intraoperative Imaging System Catalog Number: BI-700-00027

    Reason

    Navigation accuracy problem: Accuracy may fall outside of specification when used in combination with the Medtronic Synergy Experience StealthStation System Spine Software with the O-Arm Intraoperative Imaging System and tracker.

    Action

    Medtronic Navigation notified Field representatives on 11/27/07 to perform site visits to implement FCA 2007-005 - O-Arm Intraoperative Imaging System Accuracy, and deliver the Customer Letter notification. Confirmation of the visit was documented.

    Distribution

    Worldwide Distribution: USA, Canada, Czech Republic, Denmark, Germany, Netherlands, S. Korea, Poland, South Africa, and Singapore

    Quantity

    54 units