Retiro De Equipo (Recall) de RayStation and RayPlan

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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    It has been identified by emergo that some raystation/rayplan users have commissioned machines with erroneous beam profile correction parameters. these parameters affect the dose calculated in corners of large or off-axis fields. to the best of our knowledge, the issue has not caused any patient mistreatment.
  • Acción
    Emergo is requesting that users: Always validate the beam model for all clinically relevant fields, including, but not limited to, large and off-axis fields, before the system is used to create clinical treatment plans. - Carefully review all beam model parameters before commissioning. - Be aware that the Beam profile correction values may need to be adjusted in order to correctly model the primary collimator that limits the dose in the corners of large or off-axis fields. - Review any existing photon beam models to ensure that the actions above have been properly performed. Please educate physics staff about these user responsibilities. Inspect your product and identify all installed units with the above software version number(s), then confirm that you have read and understood this notice by replying to the notification email.