BEUDAMED
    FDA Recall Terminated

    Leksell GammaPlan. Leksell GammaPlan is designed for use with the Leksell Gamma Knife manufactured by Elekta Instrument AB. The Leksell GammaPlan is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. It processes the inputs of the health care professional (Neurosurgeons, Radiation Therapists and Radiation Physicists) such that the desired radiation dose is provided by the Leksell Gamma Knife to a precisely defined target area within the cranium.

    Recall: Z-1134-2010 · Initiated October 23, 2008

    Recall

    Recall Number
    Z-1134-2010
    Event Number
    54631
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    IWB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 23, 2008
    Posted
    April 27, 2010
    Terminated
    December 14, 2010
    Address
    4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, GA, 30092-3011

    Description

    Leksell GammaPlan. Leksell GammaPlan is designed for use with the Leksell Gamma Knife manufactured by Elekta Instrument AB. The Leksell GammaPlan is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. It processes the inputs of the health care professional (Neurosurgeons, Radiation Therapists and Radiation Physicists) such that the desired radiation dose is provided by the Leksell Gamma Knife to a precisely defined target area within the cranium.

    Reason

    Although the co-registration looks good during the verification step in the co-registration dialog, the obtain transformation may include an error that depends on the voxel sizes and acquisition parameters of the co-registered image studies.

    Action

    Important Notice A325 "Error in ImageMerge" dated November 21, 2008 was sent to affected customers and field service engineer as notification of the problem. The notice advises users not to use ImageMerge except if it is judged that the transformation error has no clinical significance. Information is provided in the release to help the user to make an informed decision on this issue. Field Change Order 200 084, "NTPS 8.3 SP1 for NTPS 8.0, 8.2 and 8.3" released January 28, 2009 was sent to affected customers as notification of the fix to this issue. This notice includes instructions to assist Elekta field service personnel in successfully upgrading the affected systems. Once the upgrade is in place, the issue will be corrected.

    Distribution

    Nationwide Distribution -- (AL, AZ, AR, CA, CO, FL, GA, HI, IL,KY, MA, MI, MS, NE, NV, NV, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN TX and UT).

    Quantity

    72 units