Retiro De Equipo (Recall) de Philips Ingenia 1.5T and Ingenia 3.0T MR systems with Ingenia MR-OR solution

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 II
  • 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
    There is an electrical component called mr-or laser control board in the flextrak or trolley, under the interface adapter. in production, two mr-or laser control boards have been found where the laser control board has been assembled incorrectly, leading to insufficient isolation distance. hence, there is a possibility that a patient or user may be exposed to a very small, level of touch current. in practice, the current is so low that it may not even be noticed.
  • Acción
    Philips has revised the design of the control board and is sending out service engineers to install the revised boards.



  • Empresa matriz del fabricante (2017)
  • Source