Natus neoBLUE 3 Phototherapy System Recalled for Intensity Documentation
Natus Medical is recalling 4,560 neoBLUE 3 Phototherapy systems because the instruction manuals did not accurately reflect the cleared intensity settings.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity. The hazard involves documentation accuracy regarding intensity settings rather than a direct physical defect causing immediate harm, and no injuries or illnesses are reported.
Plain-English summary
Natus Medical Incorporated is recalling 4,560 units of the neoBLUE 3 Phototherapy system (Catalogue Part Number: 010066; Top Assembly Part Number: 001103). The recall was initiated because the Instruction For Use (IFU) and Service Manuals for the neoBLUE 3 were revised to show the cleared intensity statement settings. This revision ensures that the output intensity aligns precisely with the information listed in the cleared 510(k) submission.
The affected devices were distributed nationwide. The recall is limited to specific serial numbers listed in the FDA record Z-0149-2016. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Healthcare facilities and users should check their device serial numbers against the list provided by the FDA or Natus Medical. If a device is affected, users should follow the instructions provided by the manufacturer regarding the revised documentation.
The recalled product
- Product
- Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066; Top Assembly Part Number: 001103
- Manufacturer
- Natus Medical Incorporated
- Affected units
- 4,560
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: 0.23998
- 1
- 13201
- 18002
- 18003
- 18004
- 18005
- 18006
- 18007
- 18008
- 18009
- 18010
- 18011
- 18012
- 18013
- 18015
- 18016
- 18017
- 18018
- 18019
Distribution
Distributed nationwide across the United States.
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