neoBLUE CozyRecalls & reported problems

Natus Medical Incorporated · The neoBLUE cozy™ Phototherapy System is a mobile phototherapy light that delivers a narrow band of high-intensity blue light via blue light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia. The neoBLUE cozy light was designed for use within a patient enclosure, positioned under the baby · Class 2

Data updated Oct 16, 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 00382830053198), received between Aug 9, 2018 and Aug 9, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Electromagnetic Compatibility 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

Electromagnetic Compatibility Problem1

Patient problems

No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

MalfunctionAug 9, 2018Electromagnetic Compatibility Problem; Electromagnetic Compatibility Problem
IT WAS REPORTED TO NATUS THAT A NEOBLUE COZY UNIT WAS GENERATING EXCESSIVE ARTIFACTS IN EKG EQUIPMENT WHILE EKG MONITORING. THE COMPLAINANT TRIED MULTIPLE CONFIGURATIONS OF THE EKG EQUIPMENT AND THE NEOBLUE COZY TO LIMIT THE ARTIFACT BUT WAS UNSUCCESSFUL. IT WAS REPORTED THAT THE ARTIFACT ONLY OCCURRED IN THE PRESENCE OF A NEOBLUE COZY AND NOT IN THE PRESENCE OF AN OVERHEAD NEOBLUE UNIT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR ENVIRONMENTAL/SAFETY CONCERNS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7769051 ↗

Device details

UDI-DI	`00382830053198`
Brand	neoBLUE
Model	Cozy
Catalog no.	001354
Company	Natus Medical Incorporated
Product code	LBI · Unit, Neonatal Phototherapy
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Jan 9, 2026

Device type (GMDN): Blanket/pad infant phototherapy unit

A device designed to emit a blue light in the visible wavelength of around 425-475 nm to treat neonatal jaundice (or hyperbilirubinemia). It consists of a light source that connects to a blanket-like wrap or pad which emits the light and covers or encloses the neonate's body. Exposure to this device will alter the bilirubin through photo oxidation and configurational and structural isomerization allowing the body function to dispose of it naturally. It is intended for use in the home and a clinical setting.

Other Unit, Neonatal Phototherapy devices

BiliLux Phototherapy Light MU20100
Draeger Medical Systems, Inc. · Unit, Neonatal Phototherapy
4 reports
neoBLUE LED Phototherapy System
Natus Medical Incorporated · Unit, Neonatal Phototherapy
2 reports
neoBLUE blanket Large Pad Kit
Natus Medical Incorporated · Unit, Neonatal Phototherapy
1 report

All Unit, Neonatal Phototherapy 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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