BEUDAMED
    FDA Recall Terminated

    Leksell Gamma Knife Perfexion, Product Number: 715000. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA. Intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.

    Recall: Z-1232-2010 · Initiated November 6, 2009

    Recall

    Recall Number
    Z-1232-2010
    Event Number
    55063
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    IWB
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 6, 2009
    Posted
    April 5, 2010
    Terminated
    December 14, 2010
    Address
    4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, GA, 30092-3011

    Description

    Leksell Gamma Knife Perfexion, Product Number: 715000. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA. Intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.

    Reason

    There may be a situation where the Frame Adapter might lock the stereotactic Frame in the wrong position.

    Action

    Elekta, Inc. issued a Field Change Order 200 091 titled "Update Frame Adapter with New Frame Fixation Axle" dated November 6, 2009. Consignees were given instructions to prevent further issues related to the affected device. For further information, contact Elekta, Inc. at 1-770-300-9725.

    Distribution

    Nationwide Distribution -- AZ, CA, FL, IL, KY, MI, MN, MS, MO, NY, NC, OH, OR, PA, SC, TX, UT and VA.

    Quantity

    32 units