Events

Retiro De Equipo (Recall) de DuraDiagnost X-ray System

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
    Recall
  • ID del evento
    RC-2015-RN-00089-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-01-30
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00089-1
  • 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
    During recent evaluations of the philips duradiagnost x-ray system, philips have identified a potential issue that may affect the performance of the equipment under certain conditions. 1) if all six t-nuts which are used to mount the x-ray tube arm base to the carriage were not properly assembled, the tube arm assembly could fall. 2) if all eight t-nuts which are used to mount the wall stand detector carrier box and base were not properly assembled, the wall stand detector carrier assembly could fall. 3) if all eight t-nuts which are used to mount the table base and table top floating frame were not properly assembled, the table top could be floating.
  • Acción
    A Philips Service Engineer will conduct an inspection to determine if the equipment is affected by this issue. If it is determined that the tube arm and wall stand fixture are not in the correct position the equipment should cease to be used until the tube arm and wall stand fixture have been replaced. A new tube arm and wall stand fixing structure that is designed to prevent this hazard if the tube arm or Wall stand is incorrectly reinstalled in the future will be fitted. This action has been closed-out on 18/07/2016.

Device

DuraDiagnost X-ray System

Manufacturer

Philips Electronics Australia Ltd
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DHTGA