Events

Retiro De Equipo (Recall) de MOSAIQ 2.62 and higher with the IQ Scripts license enabled (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-00781-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-06-14
  • 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-00781-1
  • 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
    Clicking on the treat button in the treatment chart window will trigger the plan-of-the-day iq script to run. the plan-of-the-day window will open and the treatment plan can be selected by clicking on the radio button. it is possible that the selected plan-of-the-day could be accidentally changed by scrolling the mouse wheel up and down and inadvertently selecting another plan.Though the wrong plan-of-the-day selected for one fraction would likely not result in critical harm, if the wrong plan were selected multiple times it could result in serious injury.
  • Acción
    The issue is corrected in the general release of MOSAIQ 2.64. A software patch will be released for MOSAIQ version 2.62 in order to correct the defect. In the interim, the problem can be avoided by careful use of a mouse with a wheel (or using a mouse without a scroll wheel) and verifying that the correct plan is chosen before selecting OK on the Plan-of-the-Day form. This action has been closed-out on 02/02/2017.

Device

MOSAIQ 2.62 and higher with the IQ Scripts license enabled (Oncology information system used to m...
  • Modelo / Serial
    MOSAIQ 2.62 and higher with the IQ Scripts license enabled (Oncology information system used to manage workflows for treatment planning and delivery)ARTG Number: 206321
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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