Home / Recalls / Neurotherm, Inc. / Z-1361-2016

Z-1361-2016 Class II Terminated

Recalled by Neurotherm, Inc. — Wilmington, MA

Recall Details

Product Type: Devices
Report Date: April 20, 2016
Initiation Date: October 9, 2013
Termination Date: April 14, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 25

Product Description

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

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.

Distribution Pattern

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

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