Events

Retiro De Equipo (Recall) de Brilliance CT and Ingenuity CT with software versions v4.13 and v4.1.4 (Computed tomography full-body 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-2016-RN-00340-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-03-23
  • 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-2016-RN-00340-1
  • 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
    On the affected ct systems and software versions, the issue relates to the auto transfer to the remote devices (such as pacs), where there is a possibility for intermittent failures to send all images/data series automatically. the images remain on the local storage device until manually transferred to the remote device.
  • Acción
    Philips is advising users of affected CT systems to assure that all images are transferred by checking that images are available on any remote devices before images/data series are deleted from local storage device. If there are missing images/data series on remote devices, the user can manually transfer images/data series to remote devices. Philips will be completing a software upgrade as a permanent fix. This action has been closed-out on 23/06/2017.

Device

Brilliance CT and Ingenuity CT with software versions v4.13 and v4.1.4 (Computed tomography full-...
  • Modelo / Serial
    Brilliance CT and Ingenuity CT with software versions v4.13 and v4.1.4 (Computed tomography full-body x-ray system)ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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