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Bilisoft 2.0
Lumitex, Inc. · Model 009765 · UDI-DI 00812432020477
LBI
Prescription
1
510(k) clearances
808
Adverse events (2 deaths)
14
Recalls
26
Facilities
Description
The BiliSoft 2.0 Phototherapy System provides light therapy for the treatment of indirect hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in a hospital or home setting. The BiliSoft 2.0 Phototherapy System emits a narrow band of blue light considered to be the most effective in the treatment of hyperbilirubinemia.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-12-11 | Lumitex Inc | There is a potential for some systems built between 2014 and Jan 2018 to have a light output falling below the recommended minimum output. This problem has been associated with exp |
| 2017-04-03 | Natus Medical Incorporated | 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 boa |
| 2016-11-18 | Ohmeda Medical | Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord |
| 2016-10-28 | Natus Medical Incorporated | neoBLUE blanket LED Phototherapy System distributed since release of the product in 2011 is recalled due to customer complaints regarding discoloration/ degradation of fiberoptic b |
| 2016-09-16 | Natus Medical Incorporated | The firm sent the Technical Bulletin to consignees who received the reliability updated neoBLUE blanket LED Phototherapy Systems between March 2016 to August 2016. The reliability |
| 2016-04-11 | Natus Medical Incorporated | 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. |
| 2015-08-05 | Natus Medical Incorporated | 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 w |
| 2015-03-16 | Natus Medical Incorporated | 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 |
| 2014-11-19 | Natus Medical Incorporated | Replacement LED Board kit of Natus neoBLUE2 Phototherapy system distributed after February 16, 2012 is subject of a Field Safety Notification because the system will exhibit a high |
| 2013-08-31 | Physician Engineered Products, Inc. | Upper limit for ambient temperature for use of the device was printed incorrectly in the instructions |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.