BEUDAMED
    FDA Recall 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 · Initiated April 30, 2013

    Recall

    Recall Number
    Z-1402-2013
    Event Number
    65060
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 30, 2013
    Posted
    May 25, 2013
    Terminated
    July 26, 2017
    Address
    400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, 30346-1227

    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.

    Action

    Elekta sent an Important Field Safety Notice (IFSN) letter dated April 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers are instructed to complete and return the FCO Action Notification Report to local Elekta Office or Representative.

    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