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Terminated

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

FDA Recall Z-1361-2016 · Posted 2016-04-09

Recalling FirmNeurotherm, Inc.
Recall StatusTerminated
Product CodeGXD
Date Initiated2013-10-09
Date Terminated2016-04-14
Product Quantity25

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.

Firm Action

Neurotherm notified consignees via telephone and guided through the process to update the software manually. The calls were initiated by Neurotherm representatives on October 09,2013.

Root Cause

Software Manufacturing/Software Deployment

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111576NT 2000 LESIONING GENERATORNeuro Therm, Inc. · 2011-09-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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