FDAMarch 16, 2015device

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 neoBLUE blanket LED Photother...

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

The hazard

neoBLUE blanket LED Phototherapy System is recalled because Natus has received feedback from some customers about early failure of the neoBLUE blanket system fiberoptic pads. These failures involve 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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