BEUDAMED
    FDA Recall Terminated

    Leksell Gamma Knife Perfexion with EXTEND Frame System, manufactured by Electa Instrument AB, Stockholm, Sweden.

    Recall: Z-0163-2011 · Initiated September 17, 2010

    Recall

    Recall Number
    Z-0163-2011
    Event Number
    56852
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    IWB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 17, 2010
    Posted
    October 28, 2010
    Terminated
    November 10, 2010
    Address
    4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, GA, 30092-3011

    Description

    Leksell Gamma Knife Perfexion with EXTEND Frame System, manufactured by Electa Instrument AB, Stockholm, Sweden.

    Reason

    The anterior fixation bar of the EXTEND mouthpiece frontpiece may separate from the dental impression tray. This may result in reduced treatment accuracy.

    Action

    Elekta issued an Important Notice: Urgent Field Safety Notice dated September 17, 2010 concerning Field Change Order 10000202003-A342 "Important Notice regarding recall of mouthpieces for EXTEND system, to all users of the EXTEND system for LGK Perfexion. the letter identified the issue and associated potential hazard, and requested the identification and return of all affected mouthpieces, and confirmation of receipt of the letter. Elekta will arrange return and replacement through local service representatives. Customers can contact Elekta concerning this recall at 770 300 9725.

    Distribution

    Nationwide Distribution: to the states of MO, VA, and WA.

    Quantity

    3 units