Events

Retiro De Equipo (Recall) de RayStation 3.0, 3.5, 4.0, 4.5, 4.7, and 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-00904-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-07-12
  • 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-00904-1
  • 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
    There is an issue with the evaluation of biological clinical goals in raystation 3.0, 3.5, 4.0, 4.5, 4.7, and 5. this issue occurs when adaptive replanning (rayadaptive) is used in combination with biological models (raybiology) and can only occur for a user licensed for rayadaptive and raybiology concurrently. biological clinical goals for an adapted plan based on a new ct (not the planning ct used for the original plan) are evaluated using incorrect dose values and will therefore display incorrect values. the issue is present in all views displaying biological clinical goals, for adapted plans based on a new ct. the magnitude of the error is irregular and largely dependent on the differences between the original planning ct and the new ct. the computed tcp/ntcp values may be smaller or larger than the correct values. the issue has not caused any patient mistreatment or other incidents.
  • Acción
    The issue will be resolved in the next version of RayStation, scheduled for market release in December 2016. In the interim, users are advised: - Do not use the values displayed for biological clinical goals in clinical decision making when performing adaptive replanning. - The user is referred to using corresponding biological objective functions or biological functions defined in the Biological Evaluation module. These are evaluated correctly. - As stated in the RayStation Instructions for Use, always evaluate the physical dose.

Device

RayStation 3.0, 3.5, 4.0, 4.5, 4.7, and 5(Radiation therapy treatment planning system)

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia