BEUDAMED
    FDA Enforcement Class II Terminated

    Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX

    Recall: Z-1361-2016 · Reported April 20, 2016

    Enforcement

    Recall Number
    Z-1361-2016
    Event ID
    73410
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Neurotherm, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    April 20, 2016
    Initiation Date
    October 9, 2013
    Classification Date
    April 9, 2016
    Termination Date
    April 14, 2016
    Address
    600 Research Dr Ste 1, N/A, Wilmington, MA, 01887-4438, United States

    Description

    Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX

    Reason

    NT2000iX software shipped with the international setting turned on. The international settings include access to Corodotomy, Bi-Polar, and No Temperature modes were not cleared in the United States for use.

    Code Info

    Serial Numbers: 2593-13, 2717-13, 2616-13, 2704-13, 2735-13, 2360-12, 2732-13, 2727-13, 2284-11, 2726-13, 2728-13, 2426-12, 2700-13, 2508-12, 2643-13, 2733-13, 2730-13, 2724-13, 2453-12, 2631-13, 2171-11, 2059-10, 2729-13 ,2294-12, 2725-13

    Distribution

    CA, CO, IA, ME, NJ, NY, SC, TX, WI

    Quantity

    25