CLASS II Device recall · Reported 22 Apr 2015 · FDA Enforcement Report

Natus neoBLUE blanket LED Phototherapy system recalled

Natus Medical is recalling Natus neoBLUE blanket LED Phototherapy system which includes the following items: 006224. The recall was initiated on 16 Mar 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesNone

Quantity recalled2611 units (1911 units in the US and 700 units outside the US)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1412-2015
FDA event ID: 70810
Recalling firm: Natus Medical, Seattle, WA
Classification: Class II
Status: Terminated
Recall initiated: 16 Mar 2015
FDA classified: 10 Apr 2015
Reported: 22 Apr 2015
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

16 Mar 2015	Recall initiated by company
10 Apr 2015	Classified by FDA	+25 days
22 Apr 2015	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

neoBLUE blanket LED Phototherapy System is recalled because Natus has received feedback from some customers about early failure of the neoBLUE blanket system fiberoptic pads. These failures involve discoloration and melting of the fiberoptic bundle at the connector that is inserted in the neoBLUE blanket light box.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Natus neoBLUE blanket LED Phototherapy system which includes the following items: 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007302 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

Where it was distributed

distributed worldwide

Questions about this recall

Why was it recalled?

Which lots are affected?

None

Where was it sold?

distributed worldwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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