Events

Retiro De Equipo (Recall) de XiO versions 4.50 and higher (Radiation therapy treatment planning system)

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-2013-RN-01278-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-11-29
  • 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-2013-RN-01278-1
  • 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
    When computing the effective depth (with bolus) to the weight point during treatment planning, xio could use the bolus density for a particular segment of the weight fan when it should be using the ct density. if the ct density is different than the bolus density, the effective depth will be incorrect which will lead to incorrect dose. the problem occurs when the computation of the bolus polygon incorrectly invades the patient contour and overlaps an area where the ct density is much different than bolus density. when the dose is computed along each fanline/depthline, an area of bolus-patient overlap is detected, the incorrect density could be assigned. there is a remote probability of a mistreatment resulting in serious injury.
  • Acción
    Elekta is advising users that if all fractions are bolused, a workaround would be to scan the patient with the bolus in place. The incorrect assignment of density to areas of bolus-patient overlap was introduced in XiO Release 4.50.00 and will be resolved in Patch Release 4.80.03 and release 5.00.01. Patch Release 4.80.03 is now available (ie, Jan 2014) and release 5.00.01 is expected to be available by March 2014. This action has been closed-out on 11/02/2016.

Device

XiO versions 4.50 and higher (Radiation therapy treatment planning system)
  • Modelo / Serial
    XiO versions 4.50 and higher (Radiation therapy treatment planning system)ARTG Number: 99769
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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