Events

Retiro De Equipo (Recall) de RaySearch RayStation 5 (Radiation therapy treatment planning 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 Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

¿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-00717-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-06-08
  • 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-00717-1
  • 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
    This notice concerns an issue found with the treatment plan report in raystation 5. for a treatment plan with multiple beam sets, the table for region of interest (roi) plan dose statistics in the report may show the statistics for a beam set dose instead of the plan dose. in the case where a clinical decision is based on the erroneous roi plan dose statistics, a patient could potentially receive a higher than acceptable radiation dose. the error can only be triggered when using a report template where statistics for a beam set dose is included as the last dose statistics prior to the plan dose statistics. for such a report template, all reports for multiple beam set plans would always be affected.
  • Acción
    Users are advised to inspect all report templates that are intended to be used for plan with multiple beam sets, and to ensure that "POI Dose Statistics (Plan)" is included immediately before "ROI Dose statistics [Plan dose]" in the report content area. A software upgrade will be implemented as a permanent correction. This action has been closed-out on 16/02/2017.

Device

RaySearch RayStation 5 (Radiation therapy treatment planning system)

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia