Recall Z-0117-2016— Natus Neurology Inc

Name: FDA recall Z-0117-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-11

Class II · Terminated

Class II FDA medical device recall by Natus Neurology Inc, initiated 2015-09-11, terminated 2016-03-08. It names one FDA 510(k) clearance: K964280. 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. Reason: When using the 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: Natus Neurology Inc
Classification: Class II
Status: Terminated
Initiated: 2015-09-11
Terminated: 2016-03-08
Firm location: Middleton, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K964280 — DG NERVUSMedelec , Ltd.·cleared 1997-01-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

When using the 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.