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
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