Home / Recalls / Medical Devices
Neurotherm, Inc. recalls Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX
Recalled April 20, 2016 · FDA recall Z-1361-2016 · Neurotherm
Hazard
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. · FDA Class II
Units
25
Sold at
CA, CO, IA, ME, NJ, NY, SC, TX, WI
Description
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.
Product
Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX
Manufacturer(s)
Neurotherm, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →