Events

Retiro De Equipo (Recall) de Brilliance CT 16 Air, 64, Big Bore, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128 and Ingenuity Flex

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-00031-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-01-14
  • 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-00031-1
  • 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
    A potential problem with the vertical motor / brake assembly on a manufacturing lot of the patient support / couch was discovered, which may result in uncommanded vertical patient support / couch motion.
  • Acción
    End users are advised that when preparing and operating the device end users are advised to take extra caution while the patient is near the patient support. If any un-commanded motion is experienced end users are requested to discontinue use of the device and to contact their local service provider. A Philips Field Service Engineer will service your system to resolve the issue. This action has been closed-out on 15/07/2016.

Device

Brilliance CT 16 Air, 64, Big Bore, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128 ...
  • Modelo / Serial
    Brilliance CT 16 Air, 64, Big Bore, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128 and Ingenuity FlexARTG number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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