Events

Retiro De Equipo (Recall) de ARIA Oncology Information System, version 11 (A suite of software modules designed to manage the entire process of a patient's course of treatment including treatment plans and image management)

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
    Recall
  • ID del evento
    RC-2012-RN-01084-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2012-10-24
  • 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-2012-RN-01084-1
  • 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 anomaly has been identified with the aria oncology information system version 11 where monitor units of one fraction may be incorrect, when partial treatment is being continued. the issue happens when a treatment is interrupted mid-field (for example, by a power loss) and the delivered monitor units for the partially treated field are entered manually in the treatment record. when the partial treatment is resumed, the system will not use the full remaining planned monitor units for the affected field, thus leaving the fraction under dosed.
  • Acción
    Varian is recommending users to implement work around instructions until a software fix is developed and implemented.

Device

ARIA Oncology Information System, version 11 (A suite of software modules designed to manage the ...
  • Modelo / Serial
    ARIA Oncology Information System, version 11 (A suite of software modules designed to manage the entire process of a patient's course of treatment including treatment plans and image management)Product code: HITAffected serial numbers: HIT0339M and HIT0339R1ARTG Number: 132638
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Varian Medical Systems Australasia Pty Ltd

Manufacturer

Varian Medical Systems Australasia Pty Ltd