Home › Device types › LBI
Unit, Neonatal Phototherapy
FDA product code LBI · Class 2 · General Hospital
123
Registered devices
808
Adverse events
14
Recalls
71
510(k) clearances
Devices with this code
Giraffe Blue Spot PT Lite — Datex-Ohmeda, Inc.modification kit phototherapy — Drägerwerk AG & Co. KGaANeoBLUE blanket LED Phototherapy — Natus Medical Denmark ApSN/A — Bistos Co., Ltd.bili-hut™ — LITTLE SPARROWS TECHNOLOGIES LLCbili-hut™ — LITTLE SPARROWS TECHNOLOGIES LLCNeoBLUE blanket LED Phototherapy — Natus Medical Denmark ApSCloud Swaddle — NEOLIGHT LLCneoBLUE — NATUS MEDICAL INCORPORATEDbili-hut™ — LITTLE SPARROWS TECHNOLOGIES LLCBiliCocoon™ Nest Disposable — NEOMEDLIGHTBiliCocoon™ Nest System — NEOMEDLIGHTbili-hut™ — LITTLE SPARROWS TECHNOLOGIES LLCneoBLUE — NATUS MEDICAL INCORPORATEDADVANCED LED PHOTOTHERAPY LAMP — ADVANCED INSTRUMENTATIONS, INC.BILI-THERAPY Spot type / Mount Type AC100-240V — ATOM MEDICAL CORPORATIONBilisoft 2.0 — Lumitex, Inc.bili-hut™ — LITTLE SPARROWS TECHNOLOGIES LLCBiliLux Phototherapy Light — DRAEGER MEDICAL SYSTEMS, INC.BiliCocoon™ Fixation System — NEOMEDLIGHTneoBLUE — NATUS MEDICAL INCORPORATEDBilisoft 2.0 — Lumitex, Inc.BILI-THERAPY Spot Type / Arm Type For F-Rail AC100-240V — ATOM MEDICAL CORPORATIONPad Cover(S) For BILI-THERAPY Pad Type(50 pcs/box) — ATOM MEDICAL CORPORATION
Recent 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 |
| 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 ha |
| 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 overheatin |
| 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/ degrada |
| 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 20 |
| 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 |
| 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 intensit |
| 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 fi |
| 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 |
| 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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