NicoletOne Software v5 — Class II medical device recall Z-0117-2016
Terminated recall by Natus Neurology Inc, reported 2015-10-21, distributed nationwide. When using the NicoletOne v5.94 software, after exiting the impedance check function and returning to the EEG
| Recall number | Z-0117-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Natus Neurology Inc, Middleton, WI, United States |
| Recall initiated | 2015-09-11 |
| Classified | 2015-10-13 |
| Reported by FDA | 2015-10-21 |
| Terminated | 2016-03-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BD, DK, IN, JP, LK, RO, RU |
| Reason classes | software |
| Model numbers | 482-649600 |
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 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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.