Agency classClass IIOur severity:High FDA (Devices)·Z-1924-2017·Announced 2017-05-10

Natus Medical Recalls neoBLUE 2 Phototherapy Lights for Intensity Defect

Natus Medical is recalling neoBLUE 2 phototherapy lights sold from 2003 to 2008 to prevent the use of replacement boards that allow higher light intensity than originally cleared.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device used for neonatal treatment where a defect could lead to higher light intensity than cleared, representing a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Natus Medical Incorporated is recalling the second generation neoBLUE LED Phototherapy Light (neoBLUE 2) with a black band, sold between 2003 and 2008. The recall is initiated to eliminate the possibility that a neoBLUE system may have a replacement board installed which allows it to be used at a higher overall light intensity than the devices were originally cleared to deliver.

The affected devices are used to provide treatment for neonatal hyperbilirubinemia. A total of 4,371 units are involved in the recall, with 3,285 units distributed in the US and 1,086 units distributed outside of the US. The products were distributed worldwide, including in the US and numerous international countries.

Hospitals and healthcare facilities should check their inventory for the specific serial numbers listed in the official recall notice and contact Natus Medical for instructions on how to proceed with the recall.

The recalled product

Product: Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008. Catalog Part Number 010066. Top Assembly Part Numbers: 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Device is used to provide treatment for neonatal…
Manufacturer: Natus Medical Incorporated
Category: Medical Device — Phototherapy
Hazard: excessive-light-intensity

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

SERIAL NUMBERS OF UNITS DISTRIBUTED TO US GOVERMENT CONSIGNEES: 12443
12444
12445
12951
13157
13158
13169
14230
16746
16747
16759
16760
16761
16762
16763
16764
16765
16766
16767
16768

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Natus Medical Incorporated

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Same hazard · excessive light intensity