Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX
FDA device recall Z-1361-2016 · posted 2016-04-09 · Terminated
Recall details
- Recalling firm
- Neurotherm, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Software Manufacturing/Software Deployment
- Status
- Terminated
- Product code
- GXD
- Quantity affected
- 25
- Distribution
- CA, CO, IA, ME, NJ, NY, SC, TX, WI
- Date initiated
- 2013-10-09
- Date posted
- 2016-04-09
- Date terminated
- 2016-04-14
- Location
- Wilmington, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NT 2000 LESIONING GENERATOR (K111576) | Neuro Therm, Inc. | 2011-09-20 |