Reported Apr 20, 2016 · Terminated
Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX
Neurotherm, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Neurotherm, Inc. · 600 Research Dr Ste 1 · Wilmington, MA · 01887-4438
Is this the product you have?
- Neurotherm
- NT2000iX RF Generator Model NumberRFG-NT -2000iX
- Lot codes and dates
- Serial Numbers
2593-132717-132616-132704-132735-132360-122732-132727-132284-112726-132728-132426-122700-132508-122643-132733-132730-132724-132453-122631-132171-112059-102729-132294-122725-13
- Serial Numbers
- Amount recalled
- 25
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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