BEUDAMED
    FDA Recall Terminated

    Elekta Leksell Stereotactic System, used for localization (spatial reference) for cranial surgery using X-ray or CT and MRI Image data.

    Recall: Z-1251-2011 · Initiated October 2, 2009

    Recall

    Recall Number
    Z-1251-2011
    Event Number
    57604
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    October 2, 2009
    Posted
    February 15, 2011
    Terminated
    February 17, 2011
    Address
    4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, GA, 30092-3011

    Description

    Elekta Leksell Stereotactic System, used for localization (spatial reference) for cranial surgery using X-ray or CT and MRI Image data.

    Reason

    New protocols for MR sequences may result in higher RF energies deposited during MR scanning, generating heat in uninsulated fixation posts.

    Action

    Elekta sent Important Notice Affected Product: Fixation Posts, A331, dated June 22, 2009. The Important Notice will be added to the Customer User manual upon receipt.

    Distribution

    Nationwide

    Quantity

    379 units