Natus Neurology Inc recalls NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data acquisition and review system, either w…

Recall date

September 11, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0117-2016

FDA classification

Class II

Brand / firm

Natus Neurology Inc

Sold / distributed

Worldwide distribution. US nationwide, INDIA, ROMANIA, DENMARK, JAPAN, AUSTRALIA, RUSSIA, BANGLADESH, SRI LANKA, BRUNEI, and UNITED ARAB EMIRATES.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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