Natus neoBLUE blanket LED Phototherapy System Recalled for Fiberoptic Pad Failures
Natus Medical Incorporated is recalling neoBLUE blanket LED Phototherapy systems due to early failure of fiberoptic pads, which may discolor and melt.
What this means for you
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. The hazard involves component failure (melting/discoloration) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Natus Medical Incorporated is recalling the neoBLUE blanket LED Phototherapy system. The recall includes specific model numbers for large and small blanket/pad configurations, as well as light boxes, distributed worldwide. The total quantity involved is 2,611 units, with 1,911 units in the US and 700 units outside the US.
The recall was initiated because Natus received customer feedback regarding early failure of the system's fiberoptic pads. These failures involve the discoloration and melting of the fiberoptic bundle at the connector that is inserted into the neoBLUE blanket light box.
The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled devices, nor does it report any specific injuries or illnesses associated with the defect.
The recalled product
- Product
- 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
- Manufacturer
- Natus Medical Incorporated
- Category
- Medical Device — Phototherapy
- Hazard
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 (1)
- None
Distribution
Distribution scope not specified by the agency.
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