Events

Retiro De Equipo (Recall) de HexaPOD evo RT Couchtop (X-ray powered radiation therapy table)

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-2014-RN-00468-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-04-23
  • 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-00468-1
  • 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
    If the screws that secure the hexapod evo rt couchtop are not adequately tightened during installation, they may loosen over time. this condition has the following possible impacts: - there may be incorrect patient repositioning if the hexapod evo rt couchtop is moved.- the hexapod evo rt couchtop could tip when a patient is in a highly extended position (which could be the case in treatments of the lower body half).
  • Acción
    Elekta is advising their customers to check each screw to determine if it is loose. If any screw is loose the HexPOD evo RT system must be taken out of service and the service engineer responsible for the equipment should be contacted. The service engineer will tighten the screws to 20 Nm before the couchtop can be used.

Device

HexaPOD evo RT Couchtop (X-ray powered radiation therapy table)
  • Modelo / Serial
    HexaPOD evo RT Couchtop (X-ray powered radiation therapy table)ARTG Number: 187340
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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