BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1361-2016 · Initiated October 9, 2013

    Recall

    Recall Number
    Z-1361-2016
    Event Number
    73410
    Firm
    Neurotherm, Inc.
    FEI Number
    3002953813
    Product Code
    GXD
    Status
    Terminated
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    October 9, 2013
    Posted
    April 9, 2016
    Terminated
    April 14, 2016
    Address
    600 Research Dr, Ste 1, Wilmington, MA, 01887-4438

    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.

    Action

    Neurotherm notified consignees via telephone and guided through the process to update the software manually. The calls were initiated by Neurotherm representatives on October 09,2013.

    Distribution

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

    Quantity

    25