Neuron-Spectrum
NEUROSOFT, OOO · Model Neuron-Spectrum-4 · UDI-DI 04650075330128
Description
The digital systems Neuron-Spectrum-4 are intended for use as digital neurophysiological systems intended for recording, processing and display biopotential signals such as Electroencephalography (EEG) and long-latency Evoked Potential (EP). Polysomnography (PSG) derives from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes. The devices are portable and can register up to 21 EEG channels, 1 polygraphic channel and 1 breath channel. The devices do not provide alarms, do not provide automated event marking and do not provide to the user any diagnostic conclusion about the patient's condition. They are intended for use in the patient care institutions, diagnostics centers, neurosurgical hospitals experimental laboratories and sleep laboratories. The patient group includes all ages and sexes.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-04 | Micromed S.p.A. | Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acquired from two or four different amplifiers used in a multiple amplifier configuratio |
| 2025-06-18 | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) | Natus received two complaints of left side labeling show impedance for right side. |
| 2024-08-12 | SEER MEDICAL PTY LTD | During CAPA investigations of sight production inconsistencies, it was highlighted that previous Electromagnetic Compatibility (EMC) assessments related to RF radiated emissions ma |
| 2023-12-08 | WAVi Co. | Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study. |
| 2020-12-21 | Nihon Kohden America Inc | Medical device non-conformance to electrical safety standard (IEC 60601-1). |
| 2019-10-11 | LIFELINES NEURO COMPANY | Potential for one of the four temporal electrode cables used in with the ElectroTek EEG system having incorrect placement labels which could lead to incorrect placement of electrod |
| 2019-10-11 | LIFELINES NEURO COMPANY | Potential for one of the four temporal electrode cables used in with the ElectroTek EEG system having incorrect placement labels which could lead to incorrect placement of electrod |
| 2018-05-15 | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) | Possible degradation of an internal electronic component over time which may cause the XLTEK EMU 40EX Breakout box to fail. It may feel hot and plastic case may start melting. |
| 2015-11-11 | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) | During an internal testing, Natus Medical Incorporated, identified that in Neuro Works 8.1 with Quantum hardware, the incoming signal is displayed with reversed polarity. |
| 2015-09-11 | Natus Neurology Inc | 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, obscuri |
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