Events

Retiro De Equipo (Recall) de Elekta Integrity R3.0 Digital Linear Accelerator

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-00375-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-04-30
  • 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-00375-1
  • 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
    The problem is that the "static tolerances" from the calibration files (loaded database) are used for beam delivery instead of the machine calculated values. a fault will occur is the loaded database is incorrect, and could cause clinical mistreatment.
  • Acción
    Elekta is advising that the solution to this problem is to upgrade to IntegrityR3.1 as soon as it is available. An updater tool will be available within the next few months and will be Field Safety Modification number 200 02 502 030. This tool is a CD disk that Elekta Service will use on each product to check tolerances and it will adjust if necessary. This is a one-time check unless there is a change to the configuration, such as a new license for the LINAC and then a new check will be needed.

Device

Elekta Integrity R3.0 Digital Linear Accelerator
  • Modelo / Serial
    Elekta Integrity R3.0 Digital Linear AcceleratorARTG Number: 191025
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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