Events

Retiro De Equipo (Recall) de SIGNA Creator and SIGNA Explorer (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-01212-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-09-14
  • 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-01212-1
  • 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
    The function of rf power monitor is to monitor the rf amplifier output power, and detect if rf transmit power exceeding the predicted amount is generated. if the rf amplifier output power exceeds the predicted sar (specific absorption rate) amount, the rf power monitor will stop the scan. if the user performs a tps (transceiver processing and storage) reset during a patient scan, the rf power monitor will be disabled for the remainder of that patient scan. this would prevent the power monitor from detecting any subsequent failure of rf transmit function. these two failures together, could result in higher than expected thermal dose to the patient and higher than expected localised heating. there have been no failures of this type reported, and no injuries reported as a result of this issue.
  • Acción
    GE Healthcare is advising users they may continue to use the system, but ensure the RF power monitor is re-enabled by initiating a new patient exam if a TPS reset is performed during a patient exam. A software upgrade will be installed as a permanent correction. This action has been closed-out on 18/05/2017.

Device

SIGNA Creator and SIGNA Explorer (MRI System)

Manufacturer

GE Healthcare Australia Pty Ltd