Events

Retiro De Equipo (Recall) de Agility (An integral beam limiting device used with linear accelerators)

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-2012-RN-00801-3
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2012-08-06
  • 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-00801-3
  • 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
    The agility beam limiting device (bld) does not support the use of dynamic multileaf collimator (dmlc) apex at this time. apex has not been integrated or classified as compatible for use with the agility. the use of these products together has not been verified or validated by elekta and they must not be used together. there are mandatory changes necessary to the agility bld interlock circuit to let you safely attach the apex device.
  • Acción
    The customers are advised not to use Apex with Agility as the combined use could cause fatal injury, clinical mistreatment or damage to the equipment. At this time, it is noted that no Australian customers currently have an Apex installed.

Device

Agility (An integral beam limiting device used with linear accelerators)
  • Modelo / Serial
    Agility (An integral beam limiting device used with linear accelerators) ARTG Number : 196919
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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