13

Jan

2016

CL II Natus Quantum with NeuroWorks Software

0

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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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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