Natus Neurology DBA Excel Tech., Ltd. (XLTEK) recalls Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus Quantum Amplifier is intended t…

Recall date

November 11, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0581-2016

FDA classification

Class II

Brand / firm

Natus Neurology DBA Excel Tech., Ltd. (XLTEK)

Sold / distributed

Worldwide Distribution: US Distribution including states of: AL, AZ, AR, CO, FL, GA, MD, MA, MN, MS, NJ, NY, OH, SC, TN, TX and UT; and countries of: INDIA, KOREA, SPAIN, SWITZERLAND, THAILAND, UNITED KINGDOM, and CANADA. .

Why it was recalled

During an internal testing, Natus Medical Incorporated, identified that in Neuro Works 8.1 with Quantum hardware, the incoming signal is displayed with reversed polarity.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 Natus NeuroWorks /SleepWorks software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals.