Events

Retiro De Equipo (Recall) de Brilliance Big Bore Oncology CT, Brilliance Big Bore Radiology CT with software version 4.2.0Used with associated Pinnacle3 Tumor LOC server (version 14.0)

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-2018-RN-00085-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-01-30
  • 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-2018-RN-00085-1
  • 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
    Philips became aware of issues with brilliance big bore ct systems running software version 4.2.0. the most significant issues are:1- efov (extended field of view) check message does not display when fov is set >600mm for a paused scan2- prefer “center x/y 0” and “disable result rotation” checkboxes checked automatically when checking the "ct simulation"3- tumor loc allows poi (point of interest) locking when a non-isocenter slice is displayed4- tracker scan completed, no images were generated5- continuous link plans the clinical scan outside the surview6- applying tilt on first mpr result, when the other axial results are unplanned causes change in scan length and number of cycles of scan7- “system is still initializing. please wait…” error8- auto locations not functioning as expected9- system ended exam before completion10- system freeze-up after pause is pressed.
  • Acción
    Philips is releasing a Field Change Order (FCO) to correct these issues. A Philips Field Service Engineer will contact users to schedule the FCO updates. In the interim, users are advised to refer to the Customer Letter for respective actions in regards to the outlined issues.

Device

Brilliance Big Bore Oncology CT, Brilliance Big Bore Radiology CT with software version 4.2.0Used...
  • Modelo / Serial
    Brilliance Big Bore Oncology CT, Brilliance Big Bore Radiology CT with software version 4.2.0Used with associated Pinnacle3 Tumor LOC server (version 14.0)ARTG Number: 98868 (Philips Electronics Australia Ltd - X-ray system, diagnostic, computed tomography, full-body)
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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