Events

Retiro De Equipo (Recall) de DX-D 600 X-ray System, Versions below 3.6

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por AGFA HealthCare Australia.

¿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-2014-RN-01247-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-11-27
  • 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-2014-RN-01247-1
  • 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 unit is equipped with safety measures to ensure no movement can occur without user interaction. however, a customer complaint reported that during normal movement’s isolated cases of unintended overhead tube crane acceleration occurred.
  • Acción
    Users are advised that in the case of an accelerated movement, release the button/pedal immediately to stop the unit and notify their Agfa HealthCare service contact at once. Agfa Healthcare will be upgrading all full automatic and semi-automatic DX-D 600 devices to Version 3.6 to eliminate this issue. This action has been closed-out on 12/08/2016.

Device

DX-D 600 X-ray System, Versions below 3.6
  • Modelo / Serial
    DX-D 600 X-ray System, Versions below 3.6All full automatic & semi-automatic devices below version 3.6ARTG Number: 173861
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    AGFA HealthCare Australia

Manufacturer

AGFA HealthCare Australia