FDANovember 11, 2015device

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 /Sle...

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

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

natus neurology dba excel tech ltd xlteknatusnatus neurology

UPCs

013926020008013926020009013926020006013926020016013926020014013926030024013926030031013926020001013926020004013926030059013926030060013926030074

Recall history

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

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