Events

Retiro De Equipo (Recall) de RayStation 3.5 and 4.0 (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-2014-RN-00173-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-02-24
  • 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-2014-RN-00173-1
  • 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
    The manufacturer has become aware of an issue found with the dose calculation in raystation 3.5 and 4.0. the error appears in some situations for bolus/external/fixation/support structures that are outside the image stack but covered by the dose grid. when converted to dose grid structures, they are cut off at the image stack boundaries (first and last slice) in the inferior-superior direction. for a bolus/external/fixation/support structure this means that the part outside the image stack does not contribute to the density distribution and the dose calculation will be affected and may result in under dosing.
  • Acción
    Emergo is advising users to avoid the creation of treatment plans where the beam passes through a support or a fixation which is not imaged and where the support or fixation is placed on the superior or inferior side of the CT stack. Emergo is recommending the external ROI is not extended past the CT stack in the inferior or superior direction. If a bolus is used for the superior or inferior beams, users are advised to image enough slices above the patient head to fit the bolus inside the CT stack. Emergo is recommending users do not use dose tracking with oblique beams entering through the superior or inferior CBCT slice. A software patch will be installed on all affected users to correct the issue.

Device

RayStation 3.5 and 4.0 (Radiation therapy treatment planning system)

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia