Company:Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Date of Enforcement Report 1/132016
Class lI:
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 Natus NeuroWorks /SleepWorks software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals.
Recall Number Z-0581-2016
REASON
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.
RECALLING FIRM/MANUFACTURER
Natus Neurology DBA Excel Tech., Ltd. (XLTEK). Oakville, CA on 11/11/2015.Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
56 (43 US, 13 OUS)
DISTRIBUTION
Nationwide and Internationally
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