FDA Device recall Z-1361-2016
Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX
- FDA Device
- Class II
- terminated
- Published 2016-04-20
On 2016-04-20 the FDA classified a Class II recall of Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX by Neurotherm, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1361-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-09 |
| Published | 2016-04-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Neurotherm |
| Distribution | CA, CO, IA, ME, NJ, NY, SC, TX, WI |
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.
Identifiers
| code_info | Serial Numbers: 2593-13, 2717-13, 2616-13, 2704-13, 2735-13, 2360-12, 2732-13, 2727-13, 2284-11, 2726-13, 2728-13,…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1361-2016%22
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