Events

Retiro De Equipo (Recall) de INNOVA 2121IQ (Cardiovascular X-ray imaging 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-2014-RN-00210-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-03-03
  • 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-00210-1
  • 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 may not boot up properly after a power-on or after a system reset. additionally it may shut down unexpectedly during an exam which may result in the total loss of real-time interventional imaging. the loss of the fluoro imaging capability may cause substantial harm to a patient, in case it happens during a "sensitive phase" of a coronary intervention.
  • Acción
    GE Healthcare is advising users to ensure a quick functional check is performed before use. GE will be correcting all affected systems.

Device

INNOVA 2121IQ (Cardiovascular X-ray imaging system)
  • Modelo / Serial
    INNOVA 2121IQ (Cardiovascular X-ray imaging system)Serial Number 589404BU3ARTG Number: 93871
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd