Natus Quantum System Recalled for Reversed Signal Polarity Display
Natus Medical is recalling 56 Quantum Systems with NeuroWorks 8.1 software because incoming signals display with reversed polarity.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, and the source text does not report any injuries, illnesses, or deaths. The hazard involves a software display error (reversed polarity) rather than a direct physical injury mechanism, fitting the criteria for a moderate severity rating.
Plain-English summary
Natus Medical Incorporated is recalling the Natus Quantum System with NeuroWorks Software (Catalog/Part Number 013926). The recall involves 56 units, with 43 distributed in the United States and 13 outside the US.
During internal testing, the manufacturer identified that in NeuroWorks 8.1 software used with Quantum hardware, the incoming signal is displayed with reversed polarity. The Natus Quantum Amplifier is intended to be used as an electroencephalograph to acquire, display, store, and archive electrophysiological signals.
The affected units were distributed worldwide, including in the US states of AL, AZ, AR, CO, FL, GA, MD, MA, MN, MS, NJ, NY, OH, SC, TN, TX, and UT, as well as in India, Korea, Spain, Switzerland, Thailand, the United Kingdom, and Canada. Users should contact Natus Medical Incorporated for further instructions regarding the recall.
The recalled product
- Product
- Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with…
- Manufacturer
- Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
- Hazard
Distribution
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