Natus neoBLUE blanket LED Phototherapy System Recalled for Fiber Optic Degradation
Natus Medical is recalling neoBLUE blanket LED Phototherapy Systems due to discoloration and degradation of the fiberoptic bundle at the pad and box connection.
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, and the source text cites customer complaints regarding degradation without reporting any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Natus Medical Incorporated is recalling the neoBLUE blanket LED Phototherapy System, a device used to treat neonatal hyperbilirubinemia. The recall is being conducted due to customer complaints regarding the discoloration and degradation of the fiberoptic bundle at the connection point between the pad and the box.
The affected units were distributed worldwide since the product's release in 2011. The recall includes 2,619 units, with 1,925 units distributed in the United States and 694 units distributed outside the United States. Specific serial numbers for units distributed to US government accounts, within the US, and outside the US are listed in the official recall documentation.
Consumers and healthcare facilities should check their inventory against the provided serial numbers. If a unit is affected, it should be removed from service and returned to Natus Medical Incorporated for repair or replacement.
The recalled product
- Product
- Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherap
- Manufacturer
- Natus Medical Incorporated
- 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 (20)
- 000104
- 000128
- 001342
- 001364
- 001367
- 001371
- 001372
- 001373
- 001374
- 001375
- 001376
- 001377
- 001391
- 001392
- 001393
- 001394
- 001441
- 001442
- 001455
- 001456
Distribution
Distributed nationwide across the United States.
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