Recall Z-1361-2016— Neurotherm, Inc.

Name: FDA recall Z-1361-2016
Creator: U.S. Food and Drug Administration
Published: 2013-10-09

Class II · Terminated

Class II FDA medical device recall by Neurotherm, Inc., initiated 2013-10-09, terminated 2016-04-14. It names one FDA 510(k) clearance: K111576. Product: Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX. Reason: 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..

Recalling firm: Neurotherm, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-10-09
Terminated: 2016-04-14
Firm location: Wilmington, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K111576 — NT 2000 LESIONING GENERATORNeuro Therm, Inc.·cleared 2011-09-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.