Neurotherm NT2000iX RF Generator recall: Software Issue
Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX
Why was Neurotherm NT2000iX RF Generator recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX
- Recalling firm
- Neurotherm, Inc.
- Quantity
- 25
- Distribution
- CA, CO, IA, ME, NJ, NY, SC, TX, WI
- Recall date
- April 20, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)