Events

Retiro De Equipo (Recall) de RaySearch RayStation 3.5, RayStation 4.0, RayStation 4.5, and RayStation 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-2015-RN-00207-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-03-19
  • 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-2015-RN-00207-1
  • 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 issue concerns an error in dynamic multileaf collimator (dmlc) dose calculation for machines where the mlc is positioned above the jaws or the jaws are fixed. the output factor correction is computed from the irradiated area of the first control point but is applied to the entire beam. if the irradiated areas of the remaining control points are significantly different from the initial area, the output factor correction used for these control points will be incorrect.The maximum possible error in dose corresponds to the span of the output factor corrections of the beam model. for example, if the output factor corrections span 0.95-1.05, the maximum theoretical error is 10%, although for most plans, the error would be less.Machines that have backup jaw and the mlc below non-fixed jaws (e.G. varian linacs) and linacs that do not have backup jaw (e.G. siemens linacs and elekta agility) are not affected.
  • Acción
    DMLC dose calculation for the affected linac types will be turned off in patch version 4.7.1 of RayStation, scheduled for market release April 2015. In the meantime, users are advised that if DMLC has been in use for affected linac types, review the beam models. The possible error in dose depends on the span of the output factor corrections. Deprecate any beam models that have been commissioned as DMLC capable for the affected linac types. Does not commission beam models as DMLC capable for the affected linac types.

Device

RaySearch RayStation 3.5, RayStation 4.0, RayStation 4.5, and RayStation 4.7 (Radiation therapy t...
  • Modelo / Serial
    RaySearch RayStation 3.5, RayStation 4.0, RayStation 4.5, and RayStation 4.7 (Radiation therapy treatment planning system)Software versions affected: 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 and 4.7.0.15ARTG Number: 195288
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia