Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX — Class II medical device recall Z-1361-2016
Terminated recall by Neurotherm, Inc., reported 2016-04-20, distributed in CA, CO, IA, ME, NJ, NY, SC, TX…. NT2000iX software shipped with the international setting turned on. The international settings include access
| Recall number | Z-1361-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Neurotherm, Inc., Wilmington, MA, United States |
| Recall initiated | 2013-10-09 |
| Classified | 2016-04-09 |
| Reported by FDA | 2016-04-20 |
| Terminated | 2016-04-14 |
| Distributed | CA, CO, IA, ME, NJ, NY, SC, TX, WI |
| Quantity | 25 |
| Reason classes | software, unapproved product |
| Serial numbers | 2059-10, 2171-11, 2284-11, 2294-12, 2360-12, 2426-12, 2453-12, 2508-12, 2593-13, 2616-13, 2631-13, 2643-13, 2700-13, 2704-13, 2717-13, 2724-13, 2725-13, 2726-13, 2727-13, 2728-13, 2729-13, 2730-13, 2732-13, 2733-13, 2735-13 |
| Model numbers | 2000IX |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1361-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.