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.
What this means for you
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 hyperbilirubinemia
- Manufacturer
- Natus Medical Incorporated
- Category
- Medical Device — Phototherapy
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
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