Retiro De Equipo (Recall) de VariSource iX Control Software

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Varian Medical Systems Australasia 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 II
  • 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
    An anomaly has been identified with the varisource ix control software. in the event a forced logoff occurs while the dummy wire is extended during a treatment session, the partial fraction generated by the system will be incorrect. the control software does not differentiate the re-start dummy sweep from the dummy sweep at the beginning of the treatment session. the control software assumes no treatment has been delivered. the partial fraction generated will be equivalent to the original full fraction. if this partial fraction is treated, this would result in re-treatment of any dwell positions actually delivered prior to the session interrupt and result in a dose greater than intended. the treatment recovery report will incorrectly indicate that no dwell positions have been treated. both the treatment delivery report and the treatment history report do correctly indicate the dwell positions treated.There have been no reports of patient injury due to this issue.
  • Acción
    Varian Medical Systems is developing a technical correction for this issue. A Technical Service representative will contact the affected hospital when this correction is available to schedule its installation. In the interim a workaround is provided in the Customer Letter.