Reported Apr 22, 2015 · Terminated
Natus neoBLUE blanket LED Phototherapy system which includes the following items: 006224 neoBLUE blanket LED…
Natus Medical Incorporated
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Natus Medical Incorporated · 5900 1st Ave S · Seattle, WA · 98108-3248
Is this the product you have?
- Natus neoBLUE blanket LED Phototherapy system
- which includes the following items006224 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 Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007302 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS
- Lot codes and dates
- None
- Amount recalled
- 2611 units (1911 units in the US and 700 units outside the US)
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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