Events

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
    Recall
  • ID del evento
    RC-2018-RN-00128-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-02-23
  • 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-2018-RN-00128-1
  • 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 manufacturer has identified that when more than one beam is defined on the same isocenter, the center beam in field (cbf) affects all beams in a way that the user may not expect.After using cbf, the resulting fields are clearly displayed in raystation/rayplan for review and approval. however, one mistreatment incident using the cbf functionality has been reported where the user failed to review the resulting beam apertures before treatment delivery.
  • Acción
    Emergo will be contacting users to update to the next version of RayStation/RayPlan. In the interim, users are advised: · Be aware that Center Beam in Field affects all beams that share the same isocenter and that apertures may be modified in a way not intended. · Do not use Center Beam in Field after having created an opposed beam. If an opposed beam has been created, delete the opposed beam and use Center Beam in Field on the remaining beam. Then recreate the opposed beam.

Device

RayStation and RayPlan
  • Modelo / Serial
    RayStation and RayPlanModel Numbers: RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2) andRayStation 7 (RayPlan 7)Serial Numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7 or7.0.0.19ARTG Number: 195288(Emergo Asia Pacific Emergo Australia - Radiation therapy treatment planning system)
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia