Events

Retiro De Equipo (Recall) de RayStation 3.0, 3.5, 4.0, 4.5 and 4.7 (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-00182-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-02-16
  • 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-2016-RN-00182-1
  • 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
    A software bug has been reported that when using certain roi (region of interest) editing tools, if simultaneously right clicking, pressing ctrl-s or ctrl-z while the left mouse button is held down, the views can appear as if the left mouse button had been released to complete editing. in order for the bug to cause saving of an unintended state, it has to be triggered during the very last edit made to the roi. saving of an unintended state may lead to ineffective and/or unintended radiation therapy. the patient views and the beam’s eye view will always be displayed correctly in the plan approval dialog and in the plan reports. closing and reloading a case will always generate correct views. dose is always computed based on the stored system state.
  • Acción
    This issue will be resolve after the installation of RayStation 5 Service Pack 1, which was released Q1 2016. In the interim, users are advised to: -Always release the left mouse button before using other keys or mouse buttons. -If the warning message “Temporary items should not be visible on approval” is displayed or if there is some suspicion that the bug may have been triggered in structure definition, either review the structures in the Plan approval dialog, or close and reload the patient case and review the structures again. This action has been closed-out on 06/02/2017.

Device

RayStation 3.0, 3.5, 4.0, 4.5 and 4.7 (Radiation therapy treatment planning system)
  • Modelo / Serial
    RayStation 3.0, 3.5, 4.0, 4.5 and 4.7 (Radiation therapy treatment planning system)Software build number : 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, 4.0.3.4, 4.5.0.19, 4.5.1.14, 4.5.2.7, 4.7.0.15, 4.7.1.10, 4.7.2.5, 4.7.3.13 or 4.7.4.4ARTG Number: 195288
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia