FDAOctober 9, 2013device

Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX

Official recall recorded by the U.S. Food & Drug Administration.

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

FDA enforcement status: Terminated

Brands named

neurotherm

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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