Recall of Natus neoBLUE 3 Phototherapy system

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Natus Medical Incorporated.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72017
  • Event Risk Class
    Class 2
  • Event Number
    Z-0149-2016
  • Event Initiated Date
    2015-08-05
  • Event Date Posted
    2015-10-21
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2016-03-17
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Unit, neonatal phototherapy - Product Code LBI
  • 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.

Device

  • Model / Serial
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  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066; Top Assembly Part Number: 001103
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Natus Medical Incorporated, 5900 1st Ave S, Seattle WA 98108-3248
  • Manufacturer Parent Company (2017)
  • Source
    USFDA