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Class 2 Device Recall NT200iX RF Generator |
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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
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Product Classification |
Generator, lesion, radiofrequency - Product Code GXD
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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
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For Additional Information Contact |
SAME 978-657-6519
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = GXD and Original Applicant = NEUROTHERM, INC.
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