Events

Retiro De Equipo (Recall) de Innova 3100, Innova 3100IQ and Innova 2100IQ Cardiovascular X-ray Imaging 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-2014-RN-00018-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-01-09
  • 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-2014-RN-00018-1
  • 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 innova system can unexpectedly stop delivering x-rays after a power-on or a reset cycle which may result in the loss of real-time interventional imaging. no injuries have been reported due to this issue.
  • Acción
    GE Healthcare is advising users to ensure the Innova system emits x-rays before starting any procedure by completing a quick system functional check. If the system displays an "X-ray not available" error message, GE is advising users to reset the system. GE Healthcare will be correcting all affected systems.

Device

Innova 3100, Innova 3100IQ and Innova 2100IQ Cardiovascular X-ray Imaging Systems
  • Modelo / Serial
    Innova 3100, Innova 3100IQ and Innova 2100IQ Cardiovascular X-ray Imaging SystemsSystem ID Numbers: 0910162006, 0910163011 and 0910064007ARTG Number: 93871
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd