Events

Retiro De Equipo (Recall) de Brilliance 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 with the following versions: (Computed tomography (CT) full-body diagnostic 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-2015-RN-00755-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-08-20
  • 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-00755-1
  • 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
    Some scans unexpectedly set the axial (z axis) scan length to a greater length than the user set in the plan.The issue occurs only when the following 3 conditions are met:· the plan employs dual-surview· the plan requests either a sagittal or a coronal reconstruction.· the gantry is tilteddue to this issue, there is a potential for undesired radiation to areas not intended to be scanned.
  • Acción
    Philips is developing a new version of software that will eliminate the defect. Deployment of this new software will begin before the end of April, 2016. All customers will be updated by the end of October, 2016. In the interim, to eliminate the possibility of the defect from occurring, the user can eliminate any one of the three conditions (identified above) needed to trigger the behaviour. If the user chooses to eliminate the reconstruction from the plan, then that reconstruction can be created after the scan is complete. This action has been closed out on 15 June 2017.

Device

Brilliance 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 with the following versions: (...
  • Modelo / Serial
    Brilliance 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 with the following versions: (Computed tomography (CT) full-body diagnostic X-ray system)4.0.x.xxxx – Any version of 4.04.1.y.xxxx – Only version up to and including 4.1.4.ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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