Reported Oct 28, 2015 · Terminated
Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066; Top Assembly Part Number:…
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 3 Phototherapy system or Neonatal Phototherapy
- Catalogue Part Number010066
- Top Assembly Part Number001103
- Lot codes and dates
- SERIAL NUMBERS
4,560 of 4,560 codes
0.23998113201180021800318004180051800618007180081800918010180111801218013180151801618017180181801918020180211802218023180401804118042180431804418045180461804718048180491805018051180521805318054180551805618057180581805918060180611806218063180641806518066180671806818069180701807118072180731807418075
- SERIAL NUMBERS
- Amount recalled
- 4560 units
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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