Events

Retiro De Equipo (Recall) de Eclipse Treatment Planning System, ARIA Radiation Oncology (treatment plan and image management application) and Acuity Radiation Therapy Simulator Software versions 11 and 13

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Varian Medical Systems Australasia Pty Ltd.

¿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-2013-RN-01301-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-12-10
  • 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-2013-RN-01301-1
  • 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 anomaly has been identified with the plan parameters workspace within eclipse treatment planning system, aria, and acuity. when a dose relevant parameter is changed and "do not clear mus and reference point dose" is selected, the monitor units (mus) may change without the user being aware of the changes. when the user follows a specific set of conditions, the dose is rescaled such that the 100% isodose is shifted to the primary reference point location. consequently, the mus for each treatment field will change and will not meet the dose prescription intended. for example, if the dose prescription percentage was 85% in the original plan, and a dose relevant parameter is changed, the dose prescription percentage will rescale to 100%. the monitor units will be correspondingly increased. thus, the plan will no longer meet the intended dose prescription.
  • Acción
    Users are advised not to use the Plan Parameters workspace to modify 3D Treatment Plans containing a 3D dose. When it is necessary to edit patient treatment plans containing 3D dose, this action must be performed in Eclipse External Beam Planning or in the applicable treatment planning system. Varian Medical Systems recommends a thorough review of treated patient plans for plans with a primary reference point with geometric location and where modifications were made in the Plan Parameter workspace. Varian Medical Systems is currently developing a technical correction for this issue. This action has been closed-out on 11/02/2016.

Device

Eclipse Treatment Planning System, ARIA Radiation Oncology (treatment plan and image management a...
  • Modelo / Serial
    Eclipse Treatment Planning System, ARIA Radiation Oncology (treatment plan and image management application) and Acuity Radiation Therapy SimulatorSoftware versions 11 and 13Product codes: H48, HIT and H77ARTG Numbers: 119983, 132638, 119995
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Varian Medical Systems Australasia Pty Ltd

Manufacturer

Varian Medical Systems Australasia Pty Ltd