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Photo-Therapy 4000
Drägerwerk AG & Co. KGaA · Model 2M22310 · UDI-DI 04048675041689
1
510(k) clearances
808
Adverse events (2 deaths)
14
Recalls
26
Facilities
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.