Events

Retiro De Equipo (Recall) de MOSAIQ Medical Oncology version 2.50.05 and higher (oncology information system used to manage workflows for treatment planning and delivery)

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-2016-RN-00954-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-07-20
  • 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-00954-1
  • 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
    It is possible that a change to an order set will not be saved in the current, open care plan when the following workflow is utilised: 1. open either the care plan edit form or the care plan instance form and leave the form open. 2. select an order set that is part of the same care plan and make a change to the order set. this can be a change to the order set name or label or a change to the drug, dose, administration instructions, etc. 3. the update made to the order set will not be saved in the current, open care plan.Although drug and/or dose information could be edited, but if substantial changes were made to drug information a new order set would be generated rather than editing an existing order set. it is more likely that the edits made would result in non-serious injury (such as administration details, order set name, etc.) there have been no injuries reported as a result of this issue.
  • Acción
    Elekta is advising users to ensure all Care Plan windows are closed prior to making and updates to Order Sets. A software correction will be implemented as a permanent correction. This action has been closed-out on 24/05/2017.

Device

MOSAIQ Medical Oncology version 2.50.05 and higher (oncology information system used to manage wo...
  • Modelo / Serial
    MOSAIQ Medical Oncology version 2.50.05 and higher (oncology information system used to manage workflows for treatment planning and delivery)ARTG Number: 225164
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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