Events

Retiro De Equipo (Recall) de MOSAIQ Medical Oncology with software version 2.50.05 and higher

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-00803-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-06-22
  • 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-00803-1
  • 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
    Elekta has identified an issue where in the care plan library, double clicking to add or delete a component/procedure to an order set does not trigger the update of the associated care plans. the care plans in the care plan library remain pointing to an obsolete version of the order set.
  • Acción
    If the Component/Procedure is edited by selecting it (instead of double clicking), the problem does not occur and the Care Plan updates as expected. A permanent fix will be made in future software release 2.65 Beta 01.

Device

MOSAIQ Medical Oncology with software version 2.50.05 and higher
  • Modelo / Serial
    MOSAIQ Medical Oncology with software version 2.50.05 and higherARTG Number: 225164
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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