Recall Z-1361-2016
Neurotherm, Inc. · initiated October 9, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX
Codes / lots: 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
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.
FDA-determined cause: Software Manufacturing/Software Deployment
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.
Details
- Recall number
- Z-1361-2016
- Initiated
- October 9, 2013
- Posted by FDA
- April 9, 2016
- Terminated
- April 14, 2016
- Product code
- GXD – Generator, Lesion, Radiofrequency
- Quantity
- 25
- Distribution
- CA, CO, IA, ME, NJ, NY, SC, TX, WI
- Recalling firm
- Neurotherm, Inc., Wilmington, MA