BEUDAMED
    FDA Enforcement Class II Terminated

    Synergy XVI Intended for radiation therapy treatment.

    Recall: Z-1724-2014 · Reported June 25, 2014

    Enforcement

    Recall Number
    Z-1724-2014
    Event ID
    68255
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Elekta, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 25, 2014
    Initiation Date
    April 23, 2014
    Classification Date
    June 16, 2014
    Termination Date
    July 17, 2017
    Address
    400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, 30346-1227, United States

    Description

    Synergy XVI Intended for radiation therapy treatment.

    Reason

    XVI can incorrectly calculate the target position of the treatment table.

    Code Info

    XVI R4.0 to R4.2.1, R4.5.0, R4.5.1, and R5.0.0 to R5.0.1

    Distribution

    Worldwide Distribution - USA including the states of AZ, CT, IA, OH, MD, MI, MN, NV, TX and VA., and the countries of India, Ireland, Malta, Netherlands, South Africa and UK.

    Quantity

    380 US