Events

Retiro De Equipo (Recall) de Vivid E9 with Software versions 112.1.0, 112.1.1, and 112.1.3 (cardiovascular ultrasound 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-2013-RN-01095-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-10-24
  • 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-2013-RN-01095-1
  • 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
    During procedures where the 4d tee (6vt-d) probe is used over an extended period of time, the vivid e9 scanner may gradually become unresponsive with the result that the vivid e9 scanner must be rebooted. this event may lead to possible risk to patients, when performing transoesophageal echocardiography (tee).
  • Acción
    GE Healthcare is providing a correction to be installed by a GE service engineer. End users are advised to reboot the scanner if it becomes unresponsive. A reboot should take approximately 2 minutes.

Device

Vivid E9 with Software versions 112.1.0, 112.1.1, and 112.1.3 (cardiovascular ultrasound system)
  • Modelo / Serial
    Vivid E9 with Software versions 112.1.0, 112.1.1, and 112.1.3 (cardiovascular ultrasound system) Affected serial numbers: between VE94165 and VE95415ARTG Number: 146317
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd