FDA-Device2017-05-10Class II
Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008. Catalog Part Number 010066. Top Assembly Part Numbers: 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Device is used to provide treatment for neonatal hyperbilirubinemia.
Natus Medical Incorporated
Hazard
The second generation neoBLUE 2 lights with a black band, sold from 2003 to 2008, are recalled so it will eliminate the possibility that a neoBLUE system may have a replacement board installed which allows it to be used at a higher overall light intensity than the devices were originally cleared to deliver.
Sold states
Worldwide Distribution - US Nationwide and in the following countries: Argentina, Australia, Austria, Belgium, Bermuda, Canada, Colombia, Croatia, Denmark, Germany, Greece, Hungary, India, Indonesia, Israel, Italy, Japan, Kenya, Kuwait, Lithuania, Morocco, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Virgin Islands (British).
Affected count
4,371 units (3,285 units in the US and 1,086 units outside of the US)
Manufactured in
5900 1st Ave S, Seattle, WA, United States
Products
Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008. Catalog Part Number 010066. Top Assembly Part Numbers: 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Device is used to provide treatment for neonatal hyperbilirubinemia.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1924-2017Don't want to check this manually?
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