Events

Retiro De Equipo (Recall) de RayStation 3.0, 3.5, or 4.0 (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-2013-RN-01103-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-10-25
  • 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-01103-1
  • 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 dose calculation error has been identified in raystation versions 3.0. 3.5, and 4.0, when elekta motorised wedges are used for a beam and the wedge angle differs from 60 degrees. the error is that the modified energy spectrum has been used not only for the wedged part of the beam but also for the open part of the wedged field. for all clinical cases investigated by the manufacturer, the deviations were at the most 3-5% in the clinically relevant areas of the plan. deviations in the 10-12% range may occur in the buildup regions where dose calculations are generally considered approximate.
  • Acción
    The issue will be resolved in RayStation patch 4.0.2 scheduled for market release in December 2013 and in all future releases. In the interim, workarounds for creating a beam with Elekta motorized wedge, without and with wedge optimization in described in the customer letter.

Device

RayStation 3.0, 3.5, or 4.0 (Radiation therapy treatment planning system)

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia