FDAApril 11, 2016device
Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066. Top Assembly Part Numbers: 001103, 001314, 002110, 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Used to provide treatment for neonatal hyperbilirubinemia
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The firm is adding the warning statement to the Instruction for Use for the neoBLUE LED Phototherapy System and provide a laminated Quick Guide to affix to each device.
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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