Recall Z-1361-2016 ยท GXD Generator, Lesion, Radiofrequency
Neurotherm, Inc.
Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX
| Date | Apr 9, 2016 (initiated Oct 9, 2013) |
| Status | Terminated |
| 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. |
| Root cause | 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 | 25 |
| Distribution | CA, CO, IA, ME, NJ, NY, SC, TX, WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111576 | NT 2000 LESIONING GENERATOR Neuro Therm, Inc., Sep 20, 2011 |