Z-1361-2016Class II

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

Name: Z-1361-2016 Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX
Creator: Neurotherm, Inc.
Published: 2013-10-09
License: https://open.fda.gov/license/

Neurotherm, Inc. / initiated 2013-10-09 / Terminated / root cause: software

FDA source

Neurotherm, Inc. began a recall of Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX on 2013-10-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1361-2016
Classification: Class II
Status: Terminated
Initiated: 2013-10-09
Posted: 2016-04-09
Terminated: 2016-04-14
Recalling firm: Neurotherm, Inc.
Product: Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX
Product code: GXD Generator, Lesion, Radiofrequency
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
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.
Quantity in commerce: 25
Distribution: CA, CO, IA, ME, NJ, NY, SC, TX, WI
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1361-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1361-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-09

Product code GXD

K111576Class IINt 2000 Lesioning GeneratorNeuro Therm, Inc. / cleared 2011-09-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)