FDA Medical Device Recalls (openFDA)
Neurotherm, Inc.: Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX
- Recall number
- Z-1361-2016
- Recalling firm
- Neurotherm, Inc.
- Product
- Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX
- Status
- Terminated
- Initiated
- 2013-10-09
- Posted
- 2016-04-09
- Terminated
- 2016-04-14
- 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
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K111576"]
- PMA numbers
- not on file
- Product code
- GXD
- Firm FEI
- 3002953813
- Firm city
- Wilmington
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28