Retiro De Equipo (Recall) de AlignRT patient positioning/tracking video camera system (when used withTrueBeam Radiotherapy Delivery 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 alphaXRT Pty Ltd.

¿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 I
  • 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
    Vision rt has been notified that unintended changes can be made to the planned couch rotation parameter during patient set-up. this can occur when a user sets a different couch rotation from the plan couch rotation while performing patient alignment with the alignrt device prior to treatment with truebeam radiotherapy delivery system.When a request to update the couch position is sent to the truebeam via the alignrt device using the move couch function, the request may not be processed as expected. if the couch rotation in the alignrt device does not match the planned couch rotation of the field selected on the truebeam, this can result in a significant change to the planned couch rotation value. when the planned value is changed, the original plan value is overwritten at the console. this will result in the treatment plan couch value being updated unintentionally and a treatment misadministration may occur. there have been no reports of patient harm due to this issue.
  • Acción
    Vision RT is advising users to not use the “Move Couch” function if the couch rotation value set in the AlignRT device does not match the planned couch rotation for the treatment field. Vision RT is investigating a solution for this issue.


  • Modelo / Serial
    AlignRT patient positioning/tracking video camera system (when used withTrueBeam Radiotherapy Delivery System)AlignRT PCR Number: 249-1526ARTG Number: 159239
  • Clasificación del producto
  • Manufacturer