FDAFDA · Food and drugs·Recall number Z-1361-2016
Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX
Published April 20, 2016 · Recall initiated: October 9, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Neurotherm, Inc.
- Distributor
- CA, CO, IA, ME, NJ, NY, SC, TX, WI
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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