Natus neoBLUE 2 Phototherapy LED Kit Recalled for Higher Light Intensity
Natus Medical is recalling replacement LED PCB kits for neoBLUE 2 phototherapy systems because they produce higher light intensity than the original device.
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 a voluntary precautionary Field Safety Notification regarding a deviation from intended light intensity without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Natus Medical Incorporated is issuing a Field Safety Notification for the Replacement LED PCB Kit, part number 001840, used in the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. The recall affects 1,907 kits distributed worldwide, including 1,413 in the United States and 494 internationally. The kits are subject to the notification because the system exhibits a higher light intensity output than the original device.
The affected kits were distributed after February 16, 2012, and are intended for use only with neoBLUE devices manufactured between 2002 and 2007. While some customers may prefer the higher intensity levels, there is a concern that patients may receive more light intensity than desired. The source text does not report any specific illnesses or injuries associated with this issue.
Healthcare providers and consumers should verify if their devices are affected by checking the distribution date and device manufacturing year. Natus Medical is the recalling firm responsible for this Field Safety Notification.
The recalled product
- Product
- Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.
- Manufacturer
- Natus Medical Incorporated
Distribution
Distribution scope not specified by the agency.
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