Events

Retiro De Equipo (Recall) de 3.0T GE 6-Channel Phased Array Flex Coil

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-2017-RN-01349-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-10-24
  • 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-2017-RN-01349-1
  • 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
    Ge healthcare has recently become aware of a potential safety issue with the 3.0t 6 channel flex coil used with the 3t mr750w surgical suite scanners. coil overheating can occur when the device is used in mode 2 setup. this could lead to a serious patient thermal injury.To date, there have been no injuries reported as a result of this issue.This action has been undertaken prior to consultation with the therapeutic goods administration (tga).
  • Acción
    GE Healthcare advised users to discontinue placing coil cables exiting towards the patient's feet. Users can continue to use Mode 1. GE Healthcare have corrected all affected units.

Device

3.0T GE 6-Channel Phased Array Flex Coil

Manufacturer

GE Healthcare Australia Pty Ltd