Events

Retiro De Equipo (Recall) de Integrity, software version R1.1, 3.0, and R3.1 (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-01290-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-12-03
  • 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-01290-1
  • 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
    During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values. if the user does not do the quality assurance (qa) procedures after the calibration, it is possible that the user will not find the error made during the calibrationif the treatment table, gantry or collimator calibration is incorrect, and the user does not perform the recommended qa procedures, it can cause clinical mistreatment, with errors up to 6cm could go undetected and repeated over a number of fractions.
  • Acción
    As an interim measure, Elekta is recommending users perform the daily QA procedures as per the Instructions for Use (IFU) and perform a daily check to ensure the magnitude and direction of the treatment table movements are correct. If a user has X-ray Volume Imager (XVI), Elekta is recommending users perform the QA procedures as per the XVI IFU and perform the daily phantom scan. All users of Integrity 3.1 software will be informed of a mandatory upgrade to software version 3.2 upon its release in February 2014. This action has been closed-out on 18/02/2016.

Device

Integrity, software version R1.1, 3.0, and R3.1 (Linear Accelerator)
  • Modelo / Serial
    Integrity, software version R1.1, 3.0, and R3.1 (Linear Accelerator)ARTG Number: 191025
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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