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U.S. Department of Health and Human Services

Class 2 Device Recall NT200iX RF Generator

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  Class 2 Device Recall NT200iX RF Generator see related information
Date Initiated by Firm October 09, 2013
Date Posted April 09, 2016
Recall Status1 Terminated 3 on April 14, 2016
Recall Number Z-1361-2016
Recall Event ID 73410
510(K)Number K111576  
Product Classification Generator, lesion, radiofrequency - Product Code GXD
Product Neurotherm NT2000iX RF Generator
Model Number: RFG-NT -2000iX
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
Recalling Firm/
Manufacturer		 Neurotherm, Inc.
600 Research Dr Ste 1
Wilmington MA 01887-4438
For Additional Information Contact SAME
978-657-6519
Manufacturer 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.
FDA Determined
Cause 2		 Software Manufacturing/Software Deployment
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.
Quantity in Commerce 25
Distribution CA, CO, IA, ME, NJ, NY, SC, TX, WI
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GXD and Original Applicant = NEUROTHERM, INC.
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