Events

Retiro De Equipo (Recall) de Eclipse Treatment Planning System v 11, 13.0, 13.5 and 13.6 using Pencil Beam Convolution (PBC) Algorithm 11.0.31(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 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-2016-RN-00064-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-01-15
  • 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-00064-1
  • 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 anomaly in pbc algorithm 11.0.31 affects eclipse versions 11, 13, 13.5 and 13.6, for arcs consisting of more than 100 segments causing eclipse to display a dose distribution that does not correspond to the calculated monitor units, which may lead to an overdose. the discrepancy is easily detectable when a phantom is used to verify the treatment plan, as advised in the user documentation. the discrepancy between the displayed dose distribution and mus increases with the number of segments above 100. when the arc has few segments above 100, the discrepancy is smaller and more difficult to detect. as the number of segments increases above 100, the discrepancy between the displayed dose and the actual dose becomes more pronounced. when an arc is comprised of significantly more than 100 segments, the arc plan will not display mu, and the arc treatment plan will become invalid and cause the treatment to be blocked. varian has not received any report of mistreatment due to this issue.
  • Acción
    Varian Medical Systems is currently investigating a permanent solution for this issue. In the interim, users are advised to NOT USE Eclipse version 11, 13, 13.5, or 13.6 with PBC 11.0.31 algorithm for conventional arc field dose calculation. Varian recommends use of the Eclipse Anisotropic Analytical Algorithm (AAA) or Acuros XB advanced dose calculation algorithm for conventional arc field dose calculation. Users can verify whether a plan generated by Eclipse version 11, 13, 13.5 or 13.6 using PBC 11.0.31 exceeds the 100 segment limit for a given field by reviewing the calculation log files. The affected fields should be evaluated by re-calculating the plan with either: AAA, Acuros XB or PBC 10.0.28 dose calculation algorithms. For conformal arc plans, fields can also be evaluated in the properties of the dynamic MLC.

Device

Eclipse Treatment Planning System v 11, 13.0, 13.5 and 13.6 using Pencil Beam Convolution (PBC) A...
  • Modelo / Serial
    Eclipse Treatment Planning System v 11, 13.0, 13.5 and 13.6 using Pencil Beam Convolution (PBC) Algorithm 11.0.31(Radiation therapy treatment planning system)Product Code: 48Multiple Serial Numbers affectedARTG Number : 119983
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Varian Medical Systems Australasia Pty Ltd

Manufacturer

Varian Medical Systems Australasia Pty Ltd