BEUDAMED
    FDA Recall Terminated

    Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066; Top Assembly Part Number: 001103

    Recall: Z-0149-2016 · Initiated August 5, 2015

    Recall

    Recall Number
    Z-0149-2016
    Event Number
    72017
    Firm
    Natus Medical Incorporated
    FEI Number
    3018859
    Product Code
    LBI
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    August 5, 2015
    Posted
    October 21, 2015
    Terminated
    March 17, 2016
    Address
    5900 1st Ave S, Seattle, WA, 98108-3248

    Description

    Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066; Top Assembly Part Number: 001103

    Reason

    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 with the information listed in the cleared 510(k) submission.

    Action

    Natus Medical starting sending the Product Labeling Change NeoBlue LED Phototherapy System letter, dated August 2015, to all affected customers. The firm also attached the electronic copy of the revised User Manual with the letter. Customers are informed that the user and service manuals related to intensity for the neoBLUE 3 system are revised. Also, while the neoBLUE system does allow the light output to be adjusted with the potentiometers to accommodate different treatment heights, the firm removed the phrase "adjustable to >50 W/cm/nm" from the specifications. If you would like a CD disk containing the updated User Manual and the Service Manual at no charge, please call Natus Technical Service at 888-496-2887.

    Distribution

    Nationwide Distribution.

    Quantity

    4560 units