Events

Retiro De Equipo (Recall) de RaySearch RayStation 5 (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-2016-RN-01364-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-10-17
  • 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-2016-RN-01364-1
  • 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
    An issue has been identified with the display of dose computed on images other than the planning ct (auxiliary ct) when using multiple patient cases in raystation 5. if a ct image set with the same frame of reference (for) as the displayed auxiliary ct set exists in another case, the dose display may be incorrect. the issue occurs when a plan in one case is used to compute dose on another image set, and when that image set has the same for as an image set in another case. this happens when using the function “compute dose on other data set” in the plan evaluation module or when computing fraction doses in the dose tracking module. the visual display of dose in the patient views can be incorrect and can be shifted and/or rotated. the display of dose in patient views, including the maximum dose position, the dynamic isodose lines and the dose grid may be incorrect. the dose value normally displayed in the upper left corner when pointing in the 2d view may be incorrect or missing.
  • Acción
    The issue will be resolved in the next version of RayStation, scheduled for market release December 2016. Until a corrected version has been installed, all affected users must maintain awareness of the issues. Specifically, be aware that when a patient has multiple cases, the following may be incorrect if there are image sets that share the same Frame of Reference residing in different cases: - Display of evaluation dose computed on another CT image set - Dose tracking fraction dose and deformed dose. In these cases, the display of the dose values in the 2D view, including the dose value shown when pointing in the view, maximum dose position, dynamic isodose lines and dose grid display may be incorrect.

Device

RaySearch RayStation 5 (Radiation therapy treatment planning system)

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia