Events

Retiro De Equipo (Recall) de SIGNA Pioneer MRI System

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-2016-RN-00242-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-03-03
  • 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-2016-RN-00242-1
  • 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
    There is a potential safety issue with a missing ferrous warning label on the signa pioneer table control box (tcb).Ferrous material in the tcb could cause unexpected attraction to the mr system’s high-strength magnetic field during servicing activities. this could create a potential risk of serious injury to service personnel who attempt to inappropriately remove the tcb from the magnetic field. there have been no events reported as a result of this issue. clinical scanning of patients is not affected by this safety notification.
  • Acción
    GE Healthcare will correct all affected products at no cost to the affected customers by applying the ferrous warning label to the TCB. These labels are expected to be available and installed by June 2016. A GE Healthcare representative will contact the affected customers to arrange for the correction.

Device

SIGNA Pioneer MRI System

Manufacturer

GE Healthcare Australia Pty Ltd