Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy Recalled by Natus Medical Incorporated Due to The neoBLUE Instruction For Use (IFU) and Service...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Natus Medical Incorporated directly.
Affected Products
Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066; Top Assembly Part Number: 001103
Quantity: 4560 units
Why Was This Recalled?
The neoBLUE Instruction For Use (IFU) and Service Manuals for the neoBLUE 3 were revised to show the cleared intensity statement settings so the output intensity aligns precisely with the information listed in the cleared 510(k) submission.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Natus Medical Incorporated
Natus Medical Incorporated has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report