Events

Retiro De Equipo (Recall) de RaySearch RayStation, version 4.0.3 (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-00489-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-04-29
  • 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-00489-1
  • 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, raysearch laboratories has identified a problem with the computation of roi voxel volumes for cases where the ct has variable slice spacing. the dose grid volumetric representation of an roi can be wrong. this affects all dose-volume properties for such rois, including dvh, dose statistics, clinical goals and constraints or objective functions. furthermore, if material override rois are used, or if the external is not represented by contours, the bug can trigger an error in the 3d dose distribution. the problem has, to the best of raysearch laboratories' knowledge, not caused any patient mistreatment.
  • Acción
    This problem will be resolved in a future release of RayStation. Customers wanting to continue to use variable slice spacing should contact their Support representative for workarounds. RayStation 4.0.3 may not be used with CT data where variable slice spacing has been used, until a workaround has been provided. For now, applicable CT scanners should, if possible, be configured to uniform slice spacing. If there are patient plans with variable CT slice spacing being used for treatment, please contact Support representative for assistance on identifying if the problem is present and workarounds. The database of patients planned with RayStation 4.0.3 should be analysed for identification of potential errors in dose analysis for completed treatments. This action has been closed-out on 01/02/2016.

Device

RaySearch RayStation, version 4.0.3 (Radiation therapy treatment planning system)

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia