Events

Retiro De Equipo (Recall) de Philips Ingenuity CT 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-2017-RN-00261-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-02-24
  • 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-2017-RN-00261-1
  • 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
    It has been identified that the couch rear subframe cover may not be strong enough in the area around the philips logo lettering to prevent cracking during normal operations. if the cover is impacted by excessive force as a result of contact with medical transportation equipment or accessories, the cover may crack, creating a potential for injury.
  • Acción
    Philips is advising users to observe the cautions included in their system user documentation and retain the recall notification with the Instructions For Use (IFU). Users are further advised to contact Philips if there are indications that their system is not operating properly. This action has been closed-out on 01/03/2018.

Device

Philips Ingenuity CT system

Manufacturer

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