Natus Medical Incorporated recalls Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066; Top Assembly Part Number:…

Recall date

August 5, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0149-2016

FDA classification

Class II

Brand / firm

Natus Medical Incorporated

Sold / distributed

Nationwide Distribution.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066; Top Assembly Part Number: 001103