Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherapy underneath the infant and can be used in a bassinet, op...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0769-2017.
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 update to prevent the early failure of the fiberoptic pads experienced by some customers on older systems. These failures on previous systems involved discoloration and melting of the fiberoptic bundle at the connector that is inserted in the neoBLUE blanket light box.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0769-2017.
Recall terminated by FDA.
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Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0769-2017.
Natus Medical Incorporated
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Natus Medical Incorporated Recall FAQ
Natus Medical Incorporated is the subject of a medical devices safety report: Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherapy underneath the infant and can be used in a bassinet, op.... The notice was published on September 16, 2016 by the U.S. Food and Drug Administration (FDA). Approximately 713 units are potentially affected.