BEUDAMED
    FDA Enforcement Class II Terminated

    Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.

    Recall: Z-1402-2013 · Reported June 5, 2013

    Enforcement

    Recall Number
    Z-1402-2013
    Event ID
    65060
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Elekta, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 5, 2013
    Initiation Date
    April 30, 2013
    Classification Date
    May 24, 2013
    Termination Date
    July 26, 2017
    Address
    400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, 30346-1227, United States

    Description

    Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.

    Reason

    Unexpected movement during beam delivery may not be detected if there are incorrect static tolerances for Linac Geometric Axes loaded in Integrity R3.0.

    Code Info

    325134, 325254, 325082, 325159, 325268, 325237, 325331, 325267, 325236, 325314, 325127, 325261, 325286, 325077, 325269, 325129, 325296, 325273, 325139, 325201, 325137, 325184, 325161, 325076, 325086, 325112, 325081, 325083, 325099, 325110, 325271

    Distribution

    USA Nationwide including the states of CA, FL, IL, MD, MA, NJ, NY, NC, ND, OH, OR, PA, TN, TX, VA, WA, DC and Puerto Rico

    Quantity

    31