Events

Retiro De Equipo (Recall) de HexaPOD evo RT System with HexaPOD evo Module

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-2018-RN-00560-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-05-22
  • 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-2018-RN-00560-1
  • 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
    Upon completion of a 6d workflow, the hexapod evo module may be in a tilted state, if it is moved to the position used for 3d (non-iguide) treatments. in a subsequent 3d workflow, a possible incorrect position of the patient, due to a tilt of the hexapod, may be difficult to detect without verification. this description is not relevant for an iguide workflow (6d). the problem occurs only when a user switches from a 6d to a 3d workflow without iguide.
  • Acción
    Elekta is advising customers the correct position will be reached when the command to move the HexaPOD to the predefined 3D position is repeated. Users must perform this additional step without a patient on the HexaPOD after each change from the 6D workflow to the 3D workflow. Please refer to the respective User Manual for details how to initiate the movement. The manufacturer is currently investigating solutions to rectify this issue. Once available, Elekta will contact users to coordinate the required actions.

Device

HexaPOD evo RT System with HexaPOD evo Module
  • Modelo / Serial
    HexaPOD evo RT System with HexaPOD evo ModuleARTG Number:187340(Elekta Pty Ltd - Table, radiation therapy, x-ray, powered)
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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