neoBLUE LED Phototherapy SystemRecalls & reported problems

Natus Medical Incorporated · The neoBLUE LED Phototherapy System is a floor-standing, 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® Phototherapy System consists of two products – the neoBLUE LED Phototherapy light source (light) and the neoBLUE LED Phototherapy roll stand. · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00382830011594), received between Apr 12, 2022 and May 11, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 reports).

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.

Most reported problems

Device problems

Material Twisted/Bent2

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionMay 11, 2022Material Twisted/Bent; Material Twisted/Bent
NB3 LED PHOTOTHERAPY, 115V, US, LIGHT ASSEMBLY - MISSING/BENT SCREW AND BENT ROLL STAND ARM. NO INJURIES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14358154 ↗
MalfunctionApr 12, 2022Material Twisted/Bent; Material Twisted/Bent
NB3 LED PHOTOTHERAPY, 115V, US, LIGHT ASSEMBLY -DEVICE FALLING INJURING STAFF. A QUESTIONNAIRE WAS SENT TO THE CUSTOMER TO OBTAIN FURTHER INFORMATION. THE DEFECTIVE UNIT HAS BEEN REQUESTED FROM THE CUSTOMER FOR FURTHER INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14086850 ↗

Device details

UDI-DI	`00382830011594`
Brand	neoBLUE LED Phototherapy System
Model	neoBLUE
Catalog no.	001103
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): Overhead infant phototherapy unit

A mains electricity (AC-powered) device designed to emit a blue light in the visible wavelength of around 425-475 nm to treat neonatal jaundice (hyperbilirubinemia). It consists of an overhead lamp consisting of several, daylight, cool white, blue, or special blue fluorescent light tubes and a Plexiglas shield placed between the phototherapy lights and the newborn to filter out ultraviolet (UV) radiation. Exposure to this device will alter the bilirubin through photo-oxidation, and configurational and structural isomerization, allowing the body to dispose of it naturally. It will typically have a built-in timer, but some may have a separate timer unit connected.

Other Unit, Neonatal Phototherapy devices

BiliLux Phototherapy Light MU20100
Draeger Medical Systems, Inc. · Unit, Neonatal Phototherapy
4 reports
neoBLUE Cozy
Natus Medical Incorporated · Unit, Neonatal Phototherapy
1 report
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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