Retiro De Equipo (Recall) de Natus neoBLUE 3 Phototherapy system

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Natus Medical Incorporated.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    72017
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0149-2016
  • Fecha de inicio del evento
    2015-08-05
  • Fecha de publicación del evento
    2015-10-21
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2016-03-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Unit, neonatal phototherapy - Product Code LBI
  • Causa
    The neoblue instruction for use (ifu) and service manuals for the neoblue 3 were revised to show the cleared intensity statement settings so the output intensity aligns precisely with the information listed in the cleared 510(k) submission.
  • Acción
    Natus Medical starting sending the Product Labeling Change NeoBlue LED Phototherapy System letter, dated August 2015, to all affected customers. The firm also attached the electronic copy of the revised User Manual with the letter. Customers are informed that the user and service manuals related to intensity for the neoBLUE 3 system are revised. Also, while the neoBLUE system does allow the light output to be adjusted with the potentiometers to accommodate different treatment heights, the firm removed the phrase "adjustable to >50 ¿W/cm¿/nm" from the specifications. If you would like a CD disk containing the updated User Manual and the Service Manual at no charge, please call Natus Technical Service at 888-496-2887.

Device

  • Modelo / Serial
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  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066; Top Assembly Part Number: 001103
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Natus Medical Incorporated, 5900 1st Ave S, Seattle WA 98108-3248
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA