Events

Retiro De Equipo (Recall) de RayStation and RayPlan

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-2017-RN-01436-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-11-23
  • 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-2017-RN-01436-1
  • 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
    It has been identified that an issue found with the electron dose calculation in raystation 3.5, raystation 4.0, raystation 4.5, raystation 4.7, raystation 5, raystation 6, rayplan 1 (raystation 4.9) and rayplan 2 (raystation 6). when calculating electron monte carlo dose with a very large number of histories, the dose calculation may be wrong.To the best of our knowledge, the issue has not caused any patient mistreatment or other incidents. however, the user must be aware of the following information to avoid incorrect dose calculations during beam modelling and treatment planning.Electron dose calculation in raystation uses a monte carlo dose engine, where a large number of particles are simulated. each simulated particle is called a history, adding to the simulated dose. the number of histories can be adjusted for each dose calculation.
  • Acción
    Operators should inspect their product and identify all installed units with the above software version number(s), then confirm you have read and understood this notice using the supplied Client Response Form. Operators should not use a number of histories above 6 million for electron dose calculation and should inspect all commissioned electron beam models for any applicator calculated with greater than 6 million histories. This issue will be resolved in the next version of RayStation, scheduled for market release in December 2017

Device

RayStation and RayPlan
  • Modelo / Serial
    RayStation and RayPlanModel or Catalogue: RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5,RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6)Multiple Lot and Serial numbersARTG number:195288
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia