Events

Recall of Natus neoBLUE LED 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
    73169
  • Event Risk Class
    Class 2
  • Event Number
    Z-2001-2016
  • Event Initiated Date
    2016-04-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143307
  • 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 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.
  • Action
    The URGENT: FIELD SAFETY NOTICE PRODUCT LABELING CHANGE neoBLUE LED Phototherapy System, dated April 2016, was went to US customers between April 11, 2016 and April 27, 2016. Natus distribution partners outside the US will receive the Letter to Distributors and they are requested to contact their downstream customers to distribute the information. The estimated date of notifying international consignees is May 31, 2016. Enclosed with this letter, customers would receive: 1) Quick Guides (2 each) which provide operating steps, information about measuring intensity, and warnings (PN 051693) 2) User manual addendum 3) Customer reply form Natus requests that this information be distributed to all associated parties within your organization that use or service this product. Please note: this communication is in addition to any prior labeling changes that you may have received from Natus. Customers should submit the Reply Form via fax to 847-949-6031 or email to mailto:Natus_Quality_Programs@natus.com. If there are any questions regarding this letter and addendum, please call Natus Technical Service at 888-496-2887.

Device

Natus neoBLUE LED Phototherapy system
  • Model / Serial
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distributed - US Nationwide in the US including American Samoa, Guam Puerto Rico and in the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Bermuda, Bolivia, Brunei Darussalam, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, , Kenya, , Kuwait, Latvia, Lithuania, Malaysia, Moldova Republic of, Morocco, Namibia, Netherlands, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia (Slovak Republic), Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Viet Nam, Virgin Islands (British), and Yemen.
  • Product Description
    Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066. || Top Assembly Part Numbers: 001103, 001314, 002110, 040906, 040904, 040756, 040758, 040658, 040680. || Product Usage: || Used to provide treatment for neonatal hyperbilirubinemia
  • Manufacturer
    Natus Medical Incorporated

Manufacturer

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