Events

Retiro De Equipo (Recall) de Precise Treatment Table ( A patient treatment support and positioning table for radiation therapy and simulation use.)

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-00927-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-08-22
  • 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-2014-RN-00927-1
  • 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
    Elekta have identified that it is possible to get a positional error with the precise treatment table. this can occur if the positional sensors are not correctly installed during corrective maintenance. the system has a software check for large positional errors which is intended to find faults, but it is possible to position the treatment table with errors greater than 5mm and no inhibits are displayed. it is possible to cause a clinical mistreatment if the patient is not in the correct position.
  • Acción
    Elekta recommends the customers to verify the accuracy of the treatment table position using the procedure as shown by the treatment room monitor (TRM) as part of the daily machine checks. Elekta will supply an improved method of check/test for service engineers to implement post maintenance on the potentiometers to ensure they have correctly installed the positional sensors. This action has been closed-out on 12/08/2016.

Device

Precise Treatment Table ( A patient treatment support and positioning table for radiation therapy...
  • Modelo / Serial
    Precise Treatment Table ( A patient treatment support and positioning table for radiation therapy and simulation use.) Serial Numbers: 124001-125803, 125807-880, 125883-899, 125902-917, 125920-949, 125952-963, 125967-125153, 126158-170, 126174-208, 126212-230, 126232-261, 126269-281, 126293-309,126318-330, 126338-126373, 126375-397, 126400-133999 & 213000+ARTG Number: 165045
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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