Moderate FDA (Devices)·Z-1361-2016·Announced 2016-04-20

Neurotherm NT2000iX RF Generator Recalled for Uncleared Software Settings

Neurotherm is recalling 25 NT2000iX RF Generators because they shipped with international software settings enabled, allowing access to modes not cleared for use in the United States.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is related to the availability of uncleared software modes rather than a direct physical defect causing immediate harm, fitting the criteria for a moderate severity score.

Plain-English summary

Neurotherm, Inc. is recalling 25 units of the Neurotherm NT2000iX RF Generator (Model Number: RFG-NT-2000iX). The recall was initiated because the devices were shipped with the international setting turned on. This configuration allows access to Corodotomy, Bi-Polar, and No Temperature modes, which are not cleared by the FDA for use in the United States.

The affected units were distributed in California, Colorado, Iowa, Maine, New Jersey, New York, South Carolina, Texas, and Wisconsin. Specific serial numbers for the recalled units are listed in the official recall record. The agency has classified this as a Class II recall.

Healthcare providers and consumers who possess these devices should stop using them and contact Neurotherm, Inc. for instructions on how to resolve the issue. The recall is necessary to prevent the use of software modes that have not received FDA clearance for the U.S. market.

The recalled product

Product: Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX
Manufacturer: Neurotherm, Inc.
Category: Medical Device — Radiofrequency Ablation
Hazard: software-error
uncleared-mode
Affected units: 25

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed in 9 states:

Same manufacturer · Neurotherm, Inc.

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