Events

Retiro De Equipo (Recall) de Philips Ingenia 1.5T and 3.0T MR Systems Shipped between 2nd December 2013 and 7th March 2014.

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-2014-RN-00786-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-07-15
  • 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-2014-RN-00786-1
  • 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
    In the ingenia rear cover set magnetic m10 nuts (four) were erroneously supplied to the installer instead of non- magnetic a4 stainless steel nuts.
  • Acción
    All Philips installation and service engineers have been alerted to this hazard. A Field Change Order with reference FCO 78100432 is being released directing Philips field service engineers to inspect the Ingenia rear cover set nuts and replace them if needed with non-magnetic stainless steel nuts. Philips is instructing the customers to contact, if required with regard to this program, quoting the reference FCO 78100432. This action has been closed-out on 04/08/2016.

Device

Philips Ingenia 1.5T and 3.0T MR Systems Shipped between 2nd December 2013 and 7th March 2014.

Manufacturer

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