FDASeptember 16, 2016device

Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherapy underneath the infant and can be used in a bassinet, open bed, radiant warmer, incubator, or while holding the infant. Affected systems including: 1) Updated light boxes (serial number xxxx004283 or greater) have pro...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The firm sent the Technical Bulletin to consignees who received the reliability updated neoBLUE blanket LED Phototherapy Systems between March 2016 to August 2016. The reliability update to prevent the early failure of the fiberoptic pads experienced by some customers on older systems. These failures on previous systems involved discoloration and melting of the fiberoptic bundle at the connector that is inserted in the neoBLUE blanket light box.

What to do

FDA enforcement status: Terminated

Brands named

natus medicalnatus

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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