Retiro De Equipo (Recall) de Discovery MR450w, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w and Discovery MR750w equipped with the GEM option products (Full body magnetic resonance imaging (MRI) systems)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por GE Healthcare Australia 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-00464-2
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-04-24
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • 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
    Ge healthcare has recently become aware of a potential safety issue with the patient table cradle emergency release handle and cradle release block mechanism of certain ge mri products. patient egress from the system can be delayed or impeded if the cradle release handle and/or cradle release block mechanism malfunctions or becomes misaligned. this could make difficult the safe removal of the patient from the system.
  • Acción
    GE Healthcare will correct all affected products. Before continued use prior to repair, GE is advising that the operator should assess patient positioning and ease of egress and cease use if cradle movement for egress is impeded. If the operator encounters difficulty in moving the cradle out because the cradle release handle does not release properly or if the cradle movement is impeded, the facility’s GE Healthcare Service Representative should be contacted so that the cradle can be inspected and necessary repairs can be made as soon as possible. This action has been closed-out on 02/02/2016.

Device

  • Modelo / Serial
    Discovery MR450w, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w and Discovery MR750w equipped with the GEM option products (Full body magnetic resonance imaging (MRI) systems)ARTG Number: 108415
  • Clasificación del producto
  • Manufacturer

Manufacturer