BEUDAMED
    FDA Enforcement Class II Terminated

    DMLC IV-ERGO - Beam shaping block for Radiation Therapy.

    Recall: Z-2157-2013 · Reported September 11, 2013

    Enforcement

    Recall Number
    Z-2157-2013
    Event ID
    66048
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Elekta, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 11, 2013
    Initiation Date
    August 15, 2013
    Classification Date
    September 4, 2013
    Termination Date
    July 28, 2015
    Address
    400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, 30346-1227, United States

    Description

    DMLC IV-ERGO - Beam shaping block for Radiation Therapy.

    Reason

    Clinical mistreatment may occur when there are errors in the clinical workflow, or settings are incorrect.

    Code Info

    EM-042, EM7-004, EM-046, EM-060, EM-047, EM-029, EM7-003, EM7-002, EM7-008, EM-062, EM-063, EM3-004, 116001, 116012, 116044, 116055, 116014, 116052, 116023, 116056, 116053, 116043, 116047, 116051, 116122, 116068, 116013, 116046

    Distribution

    Nationwide distribution: AL, CT, FL, GA, IA, MS, MO, NJ, NY, ND, OH, OK, PA, RI, TX, VA and Puerto Rico.

    Quantity

    31