BEUDAMED
    FDA Recall Terminated

    Precise Treatment Table. To be used as part of radiation therapy treatment process.

    Recall: Z-1072-2013 · Initiated March 14, 2013

    Recall

    Recall Number
    Z-1072-2013
    Event Number
    64664
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    JAI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 14, 2013
    Posted
    April 9, 2013
    Terminated
    March 17, 2015
    Address
    400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, 30346-1227

    Description

    Precise Treatment Table. To be used as part of radiation therapy treatment process.

    Reason

    The Column rotation can accidentally be moved to a different position which in the locked position.

    Action

    Elekta sent an "IMPORTANT FIELD SAFETY NOTICE" dated March 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact your local Elekta office for questions about this notice.

    Distribution

    Nationwide Distribution and Puerto Rico.

    Quantity

    443