Natus 046621Recalls & reported problems

Xltek · BrainWatch Amplifier · Class 2

All models of Natus (13)

Data updated Oct 18, 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 00382830045742), received between Jul 17, 2025 and Jul 17, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inaccurate Information” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Inaccurate Information1
Incorrect, Inadequate or Imprecise Result or Readings1

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 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Inaccurate Information; Incorrect, Inadequate or Imprecise Result or Readings; Inaccurate Information
AMPLIFIER, BRAINWATCH AND PERSYST ANALYZER -FAULTY SEIZURE DETECTIONS. THE CUSTOMER INDICATES FALSE SEIZURE BURDEN DETECTIONS ON STUDY (FALSE POSITIVE). FEEDBACK FROM THE CUSTOMER: IN ONE STUDY, THE BRAIWATCH SYSTEM CONCLUDED THAT THE PATIENT WAS HAVING A SEIZURE. THE HEATHCARE TEAM TREATED THE PATIENT FOR SEIZURE. LATER ON, WHILE NEUROLOGIST REVIEWED EEG STUDY, HE DETERMINED THAT IT'S ALL ARTIFACT AND NOT SEIZURE. IT WAS CONFIRMED BY RERUNNING THE STUDY IN CONVENTIONAL EEG SYSTEM (MODEL UNKNOWN) THAT PATIENT HAD NOT HAD A SEIZURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22530125 ↗

Device details

UDI-DI	`00382830045742`
Brand	Natus
Model	046621
Company	Xltek
Product code	OMC · Reduced- Montage Standard Electroencephalograph
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Mar 6, 2025

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 Reduced- Montage Standard Electroencephalograph devices

NA B125 VSP3.0 Patient Monitor
GE Medical Systems Information Technologies, Inc. · Reduced- montage standard electroencephalograph
2 recalls0 reports
BIS PMB4000DOC
Covidien LP · Reduced- montage standard electroencephalograph
4 reports
Sedline 9829
Masimo Corporation · Reduced- montage standard electroencephalograph
2 reports
Natus OBM00401
Xltek · Reduced- Montage Standard Electroencephalograph
1 report

All Reduced- Montage Standard 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 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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