Reported Jun 22, 2016 · Terminated
Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066. Top Assembly Part Numbers: 001103, 001314, 002110,…
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 Phototherapy system
- Catalogue Part Number010066
- Top Assembly Part Numbers
001103001314002110040906040904040756040758040658040680
- Product UsageUsed to provide treatment for neonatal hyperbilirubinemia
- Lot codes and dates
- Serial numbers of units distributed in American Samoa, Guam
- Puerto Rico and in the US
4,640 of 4,640 codes
22938.23282.23283.23289.23291.23302.23307.23471.23473.23478.23479.23480.23481.23483.23538.23697.23708.23887.23888.23895.23916.23939.23968.23969.23972.23983.23993.23994.23998040756-1040756-2110090105071055910592105951059710598106131063310634106351063610637106381063910640106421064310645106461065910660106611066210663106661066710668
- Amount recalled
- 13541 units total (7840 units in the US and 5701 units outside the US)
Where it was sold
- Nationwide
- PR
Why it was recalled
The firm is adding the warning statement to the Instruction for Use for the neoBLUE LED Phototherapy System and provide a laminated Quick Guide to affix to each device.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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