Events

Retiro De Equipo (Recall) de RayStation software versions 2.5, 3.0, 3.5, and 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-2014-RN-00144-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-02-12
  • 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-2014-RN-00144-1
  • 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
    This notice concerns an issue found with the hybrid deformable registration in raystation 2.5, 3.0, 3.5, and 4.0. rigid registration is a standard first step prior to running a hybrid deformation. the rotation component of the rigid registration computed prior to the deformable registration is not accounted for in fusion views when mapping structures (regions or points of interest) or when deforming dose.
  • Acción
    Emergo is advising their customers to ensure that the "discard rotation" option is selected in the Image Registration Module before creating a rigid registration intended to be used for hybrid deformable registration. End users can also use the ROI based deformable registration when applicable as this functionality is not affected by the error. A software patch will be release to correct this problem.

Device

RayStation software versions 2.5, 3.0, 3.5, and 4.0 (radiation therapy treatment planning system)

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia