Events

Rappel de Device Recall Natus Blue Light, neoBLUE

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
    53681
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0420-2010
  • Date de mise en oeuvre de l'événement
    2009-10-01
  • Date de publication de l'événement
    2009-11-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-09-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86314
  • 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
    phototherapy unit - Product Code LBI
  • Cause
    The clamp connecting the neoblue mini phototherapy light to the accessory pole stand can sustain stress fractures or break when excessive force is used when tightening the clamp. no injuries have been reported.
  • Action
    On 10/1/09 Natus notified domestic consignees by Urgent Product Advisory Notice letter that advised them of the issue, instructed them to inspect the clamps, and included pictures of the affected clamp. Consignees are instructed to return the recalled clamps for a new replacement to be shipped by Natus. International distribution partners were notified by letter on 10/1/2009 and instructed to identify and contact their consignees. Replacements will be sent to the distribution partner for their consignees.

Device

Device Recall Natus Blue Light, neoBLUE
  • Modèle / numéro de série
    Catalogue / Part Numbers: 010101 (110V, US, new); 010101R (110V, US, refurbish); 010102 (230V, UK, new); 010102R (230V, UK, refurbish); 010103 (230V, EUR, new); 010103R (230V, EUR, refurbish); 010104 (230V, EUR, new); 010104R (230V, EUR, refurbish).  AFFECTED SERIAL NUMBERS:  60011-60013, 60015, 60017, 60021-60029, 60031-60033, 60035, 60037, 60038, 60101-60120, 60124-60128, 60131-60324, 60327-60349, 60351-60403, 60405, 60407-60415, 60417-60507, 60509-60586, 60588-60606, 60608-60611, 60613-60845, 60847-61000, 61002-61293, 61295-61340, 61346-61574, 61577-61590, 62001-62026, 62028-62032, 62035-62145, 62147-62163, 62165-62245, 62247-62252, 62254-62309, 62311-62350, 62352-62433, 62435-62481, 62485-62634, 62636-62640, and 62642-62656.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA, Argentina, Australia, Austria, Belgium, Bermuda, Canada, Chile, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Kenya, Kuwait, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Philippines, Poland, Portugal, PR, Qatar, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, and UK
  • Description du dispositif
    The Natus Blue Light Phototherapy is also called the "neoBLUE LED Phototherapy System". The "neoBLUE mini LED Phototherapy System"
  • Manufacturer
    Natus Medical Incorporated

Manufacturer

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