Recall of NT200iX RF Generator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Neurotherm, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Generator, lesion, radiofrequency - Product Code GXD
  • 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.


  • Model / Serial
    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
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    CA, CO, IA, ME, NJ, NY, SC, TX, WI
  • Product Description
    Neurotherm NT2000iX RF Generator || Model Number: RFG-NT -2000iX
  • Manufacturer


  • Manufacturer Address
    Neurotherm, Inc., 600 Research Dr Ste 1, Wilmington MA 01887-4438
  • Source