Recall of NeoBLUE 2

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
    74474
  • Event Risk Class
    Class 2
  • Event Number
    Z-1924-2017
  • Event Initiated Date
    2017-04-03
  • Event Date Posted
    2017-04-14
  • Event Status
    Open, Classified
  • Event Country
  • 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 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 board installed which allows it to be used at a higher overall light intensity than the devices were originally cleared to deliver.
  • Action
    On April 3, 2017, Natus sent the URGENT: RECALL NOTIFICATION 2nd Generation neoBLUE LED Phototherapy Systems letter, dated March 2017, and the Reply Form to the U.S. customers. U.S. Customers are advised to follow four steps process to receive replacement lights and return affected light back to Natus in Seattle, WA for destruction. Customers should scan and email completed Reply Form to Natus_Quality_Programs@natus.com or FAX to 847-949-6031. On April 4, 2017, Natus sent the URGENT MEDICAL DEVICE RECALL/EXCHANGE 2nd Generation neoBLUE LED Phototherapy Systems letter, dated March 2017, Reply Form, Instructions to Disable neoBLUE 2 Light, neoBLUE 2 Systems Serial Number List For Their Territory to international Distribution Partners. Downstream international customers are instructed to return the affected neoBLUE lights to their Distribution Partners. International Distribution Partners follow the Instructions to Disable neoBLUE2 lights (DOC- 019983 rev A) and destroy all affected neoBLUE lights that they recover from downstream international customers. Distribution Partners can contact Natus Technical Service at 1-888-496-2887, or e-mail the Reply Form to Natus_Quality_Programs@natus.com or via fax to 847-949-6031.

Device

  • Model / Serial
    SERIAL NUMBERS OF UNITS DISTRIBUTED TO US GOVERMENT CONSIGNEES:  12443, 12444, 12445, 12951, 13157, 13158, 13169, 14230, 16746, 16747, 16759, 16760, 16761, 16762, 16763, 16764, 16765, 16766, 16767, 16768, 16769, 16770, 16771, 16772, 16773, 16774, 16784, and 16785.  **************************************************************************************************** SERIAL NUMBERS OF UNITS DISTRIBUTED TO US CONSIGNEES:  040756-1, 040756-2, 10507, 10515, 10517, 10518, 10519, 10520, 10521, 10522, 10523, 10524, 10525, 10526, 10527, 10528, 10529, 10530, 10541, 10542, 10543, 10544, 10545, 10546, 10548, 10550, 10551, 10552, 10553, 10554, 10555, 10557, 10559, 10576, 10577, 10578, 10579, 10580, 10581, 10582, 10583, 10584, 10585, 10586, 10588, 10589, 10592, 10595, 10596, 10597, 10598, 10600, 10601, 10602, 10603, 10609, 10610, 10611, 10612, 10613, 10614, 10615, 10621, 10622, 10623, 10624, 10625, 10626, 10627, 10628, 10629, 10630, 10631, 10632, 10633, 10634, 10635, 10636, 10637, 10638, 10639, 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  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and in the following countries: Argentina, Australia, Austria, Belgium, Bermuda, Canada, Colombia, Croatia, Denmark, Germany, Greece, Hungary, India, Indonesia, Israel, Italy, Japan, Kenya, Kuwait, Lithuania, Morocco, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Virgin Islands (British).
  • Product Description
    Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008. Catalog Part Number 010066. Top Assembly Part Numbers: 040906, 040904, 040756, 040758, 040658, 040680. || Product Usage: Device is used to provide treatment for neonatal hyperbilirubinemia.
  • Manufacturer

Manufacturer

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