Events

Retiro De Equipo (Recall) de Brilliance Big Bore Oncology CT and Radiology CT (with software version 4.2.0)(4D CT pulmonary phase issue)

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-00370-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-03-16
  • 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-00370-1
  • 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
    An issue has been identified where a retrospective respiratory gated 4d ct scan is performed with the bellows pulmonary gating device, the ct images might be reconstructed at a single phase, while the annotations on the images incorrectly indicate that the reconstruction is from the requested specific phases (0% to 90%). this may lead to a couple of scenarios that may result in misrepresentation of the 4d ct images with a respiratory gated 4d ct scan and reconstruction. in the event this occurs a misrepresentation of ct images may result, due to the incorrect image pulmonary phase annotation or the need to rescan the patient due to an incorrect image pulmonary phase.
  • Acción
    Philips is recommending users to follow the instructions as outlined in the recall notification letter. The letter contains information to prevent the occurrence of the scenarios as well as the corrective actions to take when they do occur.

Device

Brilliance Big Bore Oncology CT and Radiology CT (with software version 4.2.0)(4D CT pulmonary ph...
  • Modelo / Serial
    Brilliance Big Bore Oncology CT and Radiology CT (with software version 4.2.0)(4D CT pulmonary phase issue)ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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