Cl II Natus NicoletOne Software

Company:Natus Neurology Inc.
Date of Enforcement Report: 10/21/2015
Class lI:

PRODUCT

NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data acquisition and review system, either with or without synchronous digital video. The system is intended for medical purposes to record, measure, store and display full band (FbEEG) cerebral EEG and extracerebral activity for Clinical EEG, Electrocorticography (EcOG), Long Term Monitoring (LTM), Intensive Care Unit (ICU) monitoring and Polysomnography (PSG) Sleep studies. While the Nicolet Neurodiagnostic systems are capable of displaying signals, such as Sp02 and EKG, the system is NOT intended for monitoring such signals for the preservation of life, The Nicolet Neurodiagnostic systems are intended to acquire, analyze, and display data. Recall Number Z-0117-2016

REASON
Natus Neurology has discovered that when using he NicoletOne v5.94 software, after exiting the impedance check function and returning to the EEG screen, the impedance check signal remains active in waveform, obscuring the EEG signals.

RECALLING FIRM/MANUFACTURER
TNatus Neurology Inc., Middleton, WI on 9/11/2015 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
101 (88 US, 13 OUS)

DISTRIBUTION
Nationwide and Internationally

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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.