Neurotherm, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1361-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 9, 2013

Date Posted: April 20, 2016

Recall Number: Z-1361-2016

Event ID: 73410

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.

Status: Terminated

Product Quantity: 25

Code Information:

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 Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated