Events

Retiro De Equipo (Recall) de Device Recall Natus neoBLUE 2 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
    69820
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0847-2015
  • Fecha de inicio del evento
    2014-11-19
  • Fecha de publicación del evento
    2014-12-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-07-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131593
  • 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
    Neonatal phototherapy unit - Product Code LBI
  • Causa
    Replacement led board kit of natus neoblue2 phototherapy system distributed after february 16, 2012 is subject of a field safety notification because the system will exhibit a higher light intensity output than the original device. while some customers may prefer using these lights at the higher intensity levels, some are concerned that patients may receive more intensity than desired.
  • Acción
    Natus Medical has begun mailing the Urgent Recall Notification/Field Safety Notice neoBLUE LED Board Replacements letter (DOC-012737B), dated November 5, 2014, to US consignees. Natus Medical also send the Product Advisory neoBLUE LED Board Replacements letter (DOC-0012738), dated October 30, 2014, to International Distribution Partners. Both US and International consignees also received the TECHNICAL BULLETIN LED Board Kit, neoBLUE 2 LED Phototherapy System, p/n: 001840, Treatment Intensity with revised LED board for neoBLUE 2 systems (p/n: 040904 & 040906) [DOC 008353]; and the Label, neoBLUE Intensity/Height (DOC 011561). Consignees are instructed to measure the light intensity of their devices and to document that information of the device using an adhesive label that is provided. The neoBLUE 3 system and its replacement panel sold today are not affected by this issue. If there are any questions regarding this advisory letter or the attached Technical Bulletin, please call Natus Technical Service at 888-496-2887.

Device

Device Recall Natus neoBLUE 2 Phototherapy system
  • Modelo / Serial
    All distributed Natus neoBLUE 2 systems with LED PCB replacements received after February 16, 2012. For use only with neoBLUE devices manufactured between 2002 and 2007 (neoBLUE2)
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    worldwide
  • Descripción del producto
    Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.
  • Manufacturer
    Natus Medical Incorporated

Manufacturer

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