Events

Rappel de Natus neoBLUE LED Phototherapy system

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
    73169
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2001-2016
  • Date de mise en oeuvre de l'événement
    2016-04-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-12-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143307
  • 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 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
  • Modèle / numéro de série
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    Natus Medical Incorporated, 5900 1st Ave S, Seattle WA 98108-3248
  • Société-mère du fabricant (2017)
    Natus Medical Incorporated
  • Source
    USFDA