FDA Device recall Z-0117-2016
NicoletOne Software v5.94, Catalog/Part Number: 482-649600
- FDA Device
- Class II
- terminated
- Published 2015-10-21
On 2015-10-21 the FDA classified a Class II recall of NicoletOne Software v5.94, Catalog/Part Number: 482-649600 by Natus Neurology, citing 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, obscur….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0117-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-11 |
| Published | 2015-10-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Natus Neurology |
| Distribution | US |
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.
Identifiers
| code_info | Serial numbers include TS150456M, TR150171M, TR150172M, 1TR150173M, TR150174M, TS150451M, TS150452M, TR150170M, UH15011…Serial numbers include TS150456M, TR150171M, TR150172M, 1TR150173M, TR150174M, TS150451M, TS150452M, TR150170M, UH150119M, TR150169M, UR150226M, UR150227M, UR150228M, UR150229M, TS150455M, TS150457M, TS150458M, TS150454M, TS150453M, UC150184M, PN151700M, SJ150272M, TT150134M, PN151699M, UR150230M, UR150231M, and SJ150271M. |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0117-2016%22
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