BEUDAMED
    FDA Enforcement Class II Terminated

    Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments.

    Recall: Z-0234-2018 · Reported December 20, 2017

    Enforcement

    Recall Number
    Z-0234-2018
    Event ID
    78665
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Elekta Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 20, 2017
    Initiation Date
    September 1, 2017
    Classification Date
    December 12, 2017
    Termination Date
    November 5, 2019
    Address
    13723 Riverport Dr Ste 100, N/A, Maryland Heights, MO, 63043-4819, United States

    Description

    Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments.

    Reason

    Incorrect DICOM mapping of the exported collimator or couch angles from ERGO, which would lead to incorrect rotation of the collimator or couch when using a MLC device for planning.

    Code Info

    Version 1.7.3 and higher

    Distribution

    Worldwide Distribution - US Nationwide in the states of: VA, CA, TX, MO, NY, WA, NM, MA, FL, CT, OK, SC, MS, NY, GA, NC and the countries of: AUSTRALIA, BANGLADESH, BRAZIL, BULGARIA, CANADA, COLOMBIA, CZECH REPUBLIC, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, IRELAND, ITALY, JAPAN, JORDAN, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, PERU, PHILIPPINES, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, TAIWAN, THAILAND, TURKEY, VENEZUELA, and VIETNAM

    Quantity

    182