Xltek 034879Recalls & reported problems

Xltek · NeuroWorks/SleepWorks 9.3.1 Software (US) · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382830059541), received between Jul 7, 2023 and Jul 7, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Computer Software Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

Computer Software Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionJul 7, 2023Computer Software Problem; Computer Software Problem
PART LC201-U9 UPGRADE SLEEPWORKS 9.X ACQUISITION SOFTWARE WITH SPIKE / EVENT AND HIGH RES VIDEO - ISSUE REPORTED THAT WHEN MARKING EVENTS ON A PATIENT IN A REVIEW SCREEN THE EVENTS WILL ALSO BE ADDED TO A DIFFERENT PATIENT IN THE LIVE ACQUISITION WINDOW. THIS COULD LEAD TO AN IMPROPER DIAGNOSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17277861 ↗

Device details

UDI-DI	`00382830059541`
Brand	Xltek
Model	034879
Company	Xltek
Product code	OMA · Amplitude-Integrated Electroencephalograph
Class	Class 2
FDA submission	K180421
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Aug 3, 2023

Device type (GMDN): Electroencephalograph

An electrically-powered device designed for noninvasive recording of the electrical activity of the brain for display in the form of a graph [electroencephalogram (EEG)], typically to study a variety of neurological conditions, evaluate psychiatric disorders, and/or assist in localizing tumours or lesions on or near the surface of the brain. It is designed to acquire electrical signals from electrodes typically attached to the scalp and ear lobes. The results may be displayed via print-out or electronically; data interpretation and/or telemetry features may also be included.

Other Amplitude-Integrated Electroencephalograph devices

Natus OBM00002
Xltek · Amplitude-Integrated Electroencephalograph
1 recall3 reports
Natus 022419
Xltek · Amplitude-Integrated Electroencephalograph
1 report

All Amplitude-Integrated Electroencephalograph devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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