Neurotherm, Inc. recalls Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX

Recall date

October 9, 2013

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1361-2016

FDA classification

Class II

Brand / firm

Neurotherm, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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