Events

Retiro De Equipo (Recall) de Vivid and LOGIQ Ultrasound 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-2018-RN-00359-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-05-01
  • 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-2018-RN-00359-1
  • 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 identified that the system side of the power cord for certain vivid and logiq ultrasound systems may break and expose the electrical conductors leading to the risk of shock. this can lead to injuries up to and including cardiac arrhythmia or cardiac arrest. a minor injury has been reported overseas as a result of this issue.
  • Acción
    GE Healthcare will contact users to arrange for a replacement cord to be provided. In the interim, users may continue to use their system until the correction has been implemented only if the system end of the cord is not damaged. Users should ensure all power to the unit is turned off prior to removal of the power cord.

Device

Vivid and LOGIQ Ultrasound Systems
  • Modelo / Serial
    Vivid and LOGIQ Ultrasound SystemsLOGIQ 9, LOGIQ E9, Vivid 7, Vivid E7, Vivid E9, Vivid E80, Vivid E90, and Vivid E95 ultrasound systems which have been installed since April 2015 or which have received a power cord replacement since April 2015.ARTG Numbers: 126295, 146317 and 221395
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd