BEUDAMED
    FDA Enforcement Class II Terminated

    Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.

    Recall: Z-2340-2012 · Reported September 19, 2012

    Enforcement

    Recall Number
    Z-2340-2012
    Event ID
    62915
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Elekta, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    September 19, 2012
    Initiation Date
    July 27, 2012
    Classification Date
    September 10, 2012
    Termination Date
    October 6, 2014
    Address
    4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross, GA, 30092-3011, United States

    Description

    Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.

    Reason

    Information released with the product Agility did not originally contain information on compatibility with the add-on Dynamic Multileaf Collimator Apex.

    Code Info

    152599 and 152678

    Distribution

    Nationwide Distribution including DC & MD

    Quantity

    2