Retiro De Equipo (Recall) de MobileDiagnost wDR

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Philips Electronics Australia Ltd.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Philips have identified that when the operator or a bystander touches the area of the inner part of the vertical sliding column (on which the tube arm moves up or down), without paying attention of the tube arm movement, the operator's fingers can be pinched.
  • Acción
    Philips are advising that they will install a new label on affected systems. A Philips Service Engineer will contact customers when the Field Action Kit is available to be implemented. In the interim, customers may continue to use their systems, provided they follow the Instructions for Use which outlines that users keep all body parts and clothing free of the equipment to avoid getting caught or trapped within the moving components.


  • Modelo / Serial
    MobileDiagnost wDR Model Number: 712002ARTG Number: 187112(Philips Electronics Australia - X-ray system, diagnostic, general-purpose, mobile, digital)
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Source