Events

Retiro De Equipo (Recall) de Monaco (with the use of Elekta Motorised Wedges)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Elekta 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
    Recall
  • ID del evento
    RC-2017-RN-00051-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-01-10
  • 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-2017-RN-00051-1
  • 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 where the calculated dose from wedged beams can be assigned to the wrong beam. this can occur for a plan with at least two beams using the elekta motorised wedge. as a consequence, a geometric miss would result with the dose distribution not reflecting what is delivered to the patient.
  • Acción
    As a temporary fix, Elekta is advising users to change the beam index numbers belonging to the two wedged beams, such that the index numbers are exchanged for these beams, then edit the wedge angle of one of the beams. The problem will resolve itself if a recalculation is forced after the beam numbers are edited and the wedge angle is modified, A permanent fix in the form of a software update is anticipated to be released by the end of May 2017.

Device

Monaco (with the use of Elekta Motorised Wedges)
  • Modelo / Serial
    Monaco (with the use of Elekta Motorised Wedges)Software versions: V 5.10.00 (including 5.10.01, 5.10.02)V 5.11.00 (including 5.11.01)V 5.20.00ARTG Number: 215960
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

Elekta Pty Ltd
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    DHTGA