BEUDAMED
    FDA Recall Terminated

    Leksell Gamma Knife Perfexion. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA. Indicated for use in the stereotactic irradiation of intracranial structures.

    Recall: Z-1231-2010 · Initiated May 30, 2007

    Recall

    Recall Number
    Z-1231-2010
    Event Number
    54886
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    IWB
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 30, 2007
    Posted
    April 5, 2010
    Terminated
    December 28, 2010
    Address
    4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, GA, 30092-3011

    Description

    Leksell Gamma Knife Perfexion. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA. Indicated for use in the stereotactic irradiation of intracranial structures.

    Reason

    There has been an issue with "Image Fushing" where low precision calculation caused images to become inaccurate.

    Action

    Elekta, Inc. issued a Field Change Order, Reference Number 0000946 dated March 14, 2008. Consignees were informed of the affected product and instructed on necessary steps to take. For further information, contact Elekta, Inc. at 1-770-300-9725.

    Distribution

    Nationwide Distribution -- AR, AZ, CA, FLA, IL, MI, MN, MO, MS, NJ, OH, OR, PA, UT and VA.

    Quantity

    18 units