Model note · EEG

Natus Xltek EEG system

Name: Natus Xltek EEG system
Brand: Xltek

The Natus Xltek EEG system records routine and long term video EEG in neurophysiology departments and epilepsy monitoring units, with signals captured by a headbox such as the EMU40EX and reviewed in Natus NeuroWorks software. The EMU40EX headbox takes 40 referential EEG channels plus DC, pulse and oximetry inputs, and can link to its base unit either by cable or by a secure Bluetooth connection so patients can move around during monitoring.

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The model

Maker, model and type.

Maker: Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek), Oakville, Ontario
Model: Natus Xltek EEG system with EMU40EX EEG headbox and NeuroWorks software
Device type: EEG
Main document: Open the public document

Key specifications

What the public record says.

Item	Value	Source
Referential channels	40	Source
DC channels	Four isolated DC inputs	Source
Other inputs	Oximeter connection, photic stimulator connection and patient event button	Source
Electrode connections	Touch proof, including common input	Source
Headbox power	Two rechargeable AAA cells; compatible with a rechargeable external battery pack	Source
Link to base unit	Cable or secure Bluetooth wireless link	Source
Base unit controls	Touchscreen LCD (EMU40EX) in place of the EMU40's LCD with four buttons	Source
Standards	IEC 60601-1, 60601-1-2, 60601-2-26, ISO 80601-2-61 for the oximetry function	Source
FDA clearance	510(k) K163163 (special), decision 14 December 2016, product code GWQ; predicate EMU40 headbox K053386	Source

Recalls

Known FDA recalls.

Z-2570-20182018-05-15
EMU40EX breakout box internal component may degrade, causing failure, heat and melting of the case.
FDA record
Z-1068-20152015-01-02
EPWorks software on the Xltek Protektor stimulator (intraoperative monitoring, related Xltek product) showed a remote monitoring software error.
FDA record

Safety

Safety warnings from the record.

A failing breakout box may become hot and its plastic case may melt. Source
Loss of AC ground on the acquisition PC was assessed by Natus as an electric shock hazard to users. Source
Output must be reviewed and interpreted by trained professionals; the device does not diagnose on its own. Source

Sources

Where this note comes from.

Not covered: The Natus product pages blocked automated access and the EMU40/EMU40EX user and service manual is only on a third party library behind a terms agreement, so sampling rates, bandwidth, battery run time and any headbox or NeuroWorks error messages could not be confirmed; MAUDE holds only a handful of Xltek reports.

BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.

EEG