BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1072-2013 · Reported April 17, 2013

    Enforcement

    Recall Number
    Z-1072-2013
    Event ID
    64664
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Elekta, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 17, 2013
    Initiation Date
    March 14, 2013
    Classification Date
    April 9, 2013
    Termination Date
    March 17, 2015
    Address
    400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, 30346-1227, United States

    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.

    Code Info

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    Distribution

    Nationwide Distribution and Puerto Rico.

    Quantity

    443