Events

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
    Recall
  • Event ID
    73410
  • Event Risk Class
    Class 2
  • Event Number
    Z-1361-2016
  • Event Initiated Date
    2013-10-09
  • Event Date Posted
    2016-04-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-04-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144151
  • 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.

Device

NT200iX RF Generator
  • 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
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, CO, IA, ME, NJ, NY, SC, TX, WI
  • Product Description
    Neurotherm NT2000iX RF Generator || Model Number: RFG-NT -2000iX
  • Manufacturer
    Neurotherm, Inc.

Manufacturer

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