Model note · Phototherapy Unit

Natus neoBLUE LED Phototherapy System

Name: Natus neoBLUE LED Phototherapy System
Brand: Natus

The neoBLUE is a mobile overhead LED phototherapy light used in neonatal units and postnatal wards to treat neonatal hyperbilirubinaemia. It shines a narrow band of blue light matched to bilirubin absorption, with two factory calibrated intensity settings, and can stand on its roll stand or sit directly on a flat topped incubator. Yellow LEDs are mixed in so the light looks less blue to staff.

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The model

Maker, model and type.

Maker: Natus Medical Incorporated
Model: neoBLUE LED Phototherapy System (overhead light)
Device type: Phototherapy Unit
Main document: Open the public document

Key specifications

What the public record says.

Item	Value	Source
Light source	Blue LEDs peaking at 450 to 475 nm plus yellow LEDs peaking at 585 to 595 nm	Source
Intensity at 30.5 cm (12 in)	Low 15 plus or minus 2 microW/cm2/nm; high 35 plus or minus 3.5 microW/cm2/nm	Source
Effective surface area at 30.5 cm	50 x 25 cm, intensity ratio above 0.4 (minimum to maximum)	Source
Stability and heat	Under 10% intensity variation over 6 hours; under 10 C above ambient at 30.5 cm over 6 hours	Source
Electrical	100 to 240 V, 50/60 Hz, 3 A; Class 1; fuses M4AL250 (100 to 120 V, REF 001103) or M2AL250 (200 to 240 V, REF 001314)	Source
Weight	Under 4.5 kg light enclosure only; under 18 kg with roll stand	Source
Lens height on roll stand	Adjustable from about 1.07 m to 1.50 m; enclosure tilts 0 to about 40 degrees	Source
Operating conditions	15 to 35 C, 10 to 90% RH non condensing	Source
LED life	Life testing showed over 50,000 hours of high intensity output; an hour meter logs total on time	Source
FDA clearance	K160305, 21 CFR 880.5700, product code LBI, predicate K022196	Source

Recalls

Known FDA recalls.

Z-1924-20172017-04-03
neoBLUE 2 lights sold 2003 to 2008 recalled so no unit could carry a replacement board allowing higher than cleared intensity.
FDA record
Z-2001-20162016-04-11
A warning statement was added to the IFU and a laminated quick guide supplied for each device.
FDA record
Z-0149-20162015-08-05
neoBLUE 3 IFU and service manual revised so intensity settings matched the cleared 510(k).
FDA record
Z-0847-20152014-11-19
Replacement LED PCB kit 001840 for neoBLUE 2 produced higher output than the original device.
FDA record

Safety

Safety warnings from the record.

Always protect the infant's eyes with correctly sized eye shields and do not look straight into the LEDs. Source
Do not place the light directly under a radiant heat source, and monitor skin temperature because the light can change heat balance in incubators and warmers. Source
Congenital porphyria, a family history of it, or photosensitising drugs are contraindications. Source
Switch the light off to assess skin colour, since blue light can hide cyanosis. Source
Do not use the light with a missing or damaged lens, and do not cover the vents with drapes. Source
Never spray liquids onto the light or immerse it, and avoid caustic or abrasive cleaners and solvents such as acetone; use only the disinfectants the manual lists as safe (it names 70% isopropyl and 5% bleach among them). Source

Sources

Where this note comes from.

Not covered: The unit has no numbered error codes in the user manual, and the neoBLUE service manual was not reachable from an official public source. Natus's product page (manufacturerUrl) was located by search but refused direct access, so no facts are taken from it. Most neoBLUE brand MAUDE reports (melting and overheating) and three recalls concern the separate neoBLUE blanket fibreoptic pad, which is excluded here; the plain NEOBLUE brand entries may still include some blanket 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.

Phototherapy Unit