BEUDAMED
    FDA Recall Terminated

    Medtronic Integrated Power Console System, IP X1 REF 1898001 or REF EC300 Medtronic Xomed, Inc., 6743 Southpoint Drive North, Jacksonville, FL 32216-0980 USA. Distributed by: Medtronic Powered Surgical Solutions, 4620 North Beach Street, Fort Worth, TX 76137 USA. No difference between two referenced Consoles (REF numbers differ for internal sales tracking purposes).

    Recall: Z-0259-2010 · Initiated July 17, 2009

    Recall

    Recall Number
    Z-0259-2010
    Event Number
    53603
    Firm
    Medtronic Xomed, Inc.
    FEI Number
    1045254
    Product Code
    ERL
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 17, 2009
    Posted
    November 13, 2009
    Terminated
    January 20, 2010
    Address
    6743 Southpoint Dr N, Jacksonville, FL, 32216-6218

    Description

    Medtronic Integrated Power Console System, IP X1 REF 1898001 or REF EC300 Medtronic Xomed, Inc., 6743 Southpoint Drive North, Jacksonville, FL 32216-0980 USA. Distributed by: Medtronic Powered Surgical Solutions, 4620 North Beach Street, Fort Worth, TX 76137 USA. No difference between two referenced Consoles (REF numbers differ for internal sales tracking purposes).

    Reason

    An error code (Code 13) is displayed on some of the consoles when a Medtronic Stylus or EHS handpiece is connected to the IPC indicating that the handpiece has not been recognized by the console.

    Action

    A Product Correction Notification was issued to each consignee on June 15, 2009. Medtronic sales representatives will visit each facility to advise consignees of the issue and to install a software upgrade that will correct the handpiece recognition issue on the console(s).

    Distribution

    Worldwide Distribution

    Quantity

    493