Retiro De Equipo (Recall) de Device Recall EOS 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 Eos Imaging Inc.

¿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
    62621
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2072-2012
  • Fecha de inicio del evento
    2012-06-19
  • Fecha de publicación del evento
    2012-09-28
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2013-09-16
  • 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
    Solid state x-ray imager ( flat panel/digital imager) - Product Code MQB
  • Causa
    It was discovered of several generator failures of the eos system due to failure of its anode controller board that drives the rotation of the x-ray tube anode.
  • Acción
    EOS Imaging notified users by letter on 6/19/12 and that an on site correction would be performed by an EOS Imaging Field Service engineer. EOS indicated in its notification that although this specific defect has not been observed in EOS systems installed in the U.S, they will replace the anode driver boards with new boards equipped with high current capacitors. Similarly, the generator firmware will be upgraded with the software patch that improves the cooling fans' controls. This will be replaced at no charge to the customers, during regularly scheduled preventative maintenance of the user's EOS system. This should be completed by the end of calendar year 2012. Your proposed CAP appears to adequately address the issues you raised in your notification, and is hereby approved. Your proposed customer notification letter as revised, appears to adequately provide instructions with respect to the use of the product pending the correction of the defect and it appears to provide a clear evaluation in nontechnical terms of the potential hazards related to the defect. Your proposed notification letter is hereby approved for distribution to all affected parties. Further questions please call 678-564-5400.

Device

  • Modelo / Serial
    All associated Serial Numbers
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution
  • Descripción del producto
    EOS X-ray Medical Diagnostic , X-ray Equipment System || Digital Radiography used in general radiographic examination.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Eos Imaging Inc, 185 Alewife Brook Pkwy Ste 410, Cambridge MA 02138-1104
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA