BEUDAMED
    FDA Recall Terminated

    Elekta Leksell Gamma Plan Product Usage: Gamma Plan is a computer based system designed for Gamma Knife treatment planning.

    Recall: Z-0307-2012 · Initiated June 23, 2011

    Recall

    Recall Number
    Z-0307-2012
    Event Number
    60125
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    IWB
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    June 23, 2011
    Posted
    November 30, 2011
    Terminated
    January 31, 2012
    Address
    4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, GA, 30092-3011

    Description

    Elekta Leksell Gamma Plan Product Usage: Gamma Plan is a computer based system designed for Gamma Knife treatment planning.

    Reason

    There is a risk that the user may interpret the instructions in the manual too literally, and adjust the TMR 10 dose description to obtain an ETCPD that matches previous clinical prescriptions, which in turn could lead to a prescription dose that deviates a few percent from the intended dose.

    Action

    Elekta sent an IMPORTANT NOTICE letter dated June 23, 2011 to affected customers. The notice identified the product, problem, and corrective actions to be taken by the user. The letter advise all customers to follow any instructions or recommendations covered in the Notice. The letter states that Elekta is working on a new software version and customers will receive the future version when released. For questions contact your local Elekta representative.

    Distribution

    Nationwide Distribution (USA) - including the states of: NM and WA

    Quantity

    2