Rappel de NeoBLUE 2

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Natus Medical Incorporated.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    74474
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1924-2017
  • Date de mise en oeuvre de l'événement
    2017-04-03
  • Date de publication de l'événement
    2017-04-14
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Unit, neonatal phototherapy - Product Code LBI
  • Cause
    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

  • Modèle / numéro de série
    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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  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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).
  • Description du dispositif
    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

  • Adresse du fabricant
    Natus Medical Incorporated, 5900 1st Ave S, Seattle WA 98108-3248
  • Société-mère du fabricant (2017)
  • Source
    USFDA