BEUDAMED
    FDA Recall Terminated

    Leksell Gamma Knife. Leksell Gamma Knife is a teletherapy device indicated for use in the stereotactic irradiation of intracranial structures

    Recall: Z-1236-2010 · Initiated October 1, 2007

    Recall

    Recall Number
    Z-1236-2010
    Event Number
    55001
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    IWB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 1, 2007
    Posted
    April 13, 2010
    Terminated
    December 28, 2010
    Address
    4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, GA, 30092-3011

    Description

    Leksell Gamma Knife. Leksell Gamma Knife is a teletherapy device indicated for use in the stereotactic irradiation of intracranial structures

    Reason

    After updating the LGK actuator in spare part 810361, the old sleigh became obsolete due to causing insufficient locking of the helmet in combination with the new actuator.

    Action

    Field Change Order 0000203 "Replacement of obsolete actuator sleigh on Helmet Changer", was sent to all customers that were affected. Direct questions to Elekta, Inc. by calling 1-770-670-2548.

    Distribution

    United States (CA, TN, TX and WA) and Taiwan.

    Quantity

    5 units