Events

Retiro De Equipo (Recall) de Discovery IGS 730

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-00332-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-04-13
  • 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-00332-1
  • 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 become aware of a potential loss of imaging mode during an interventional procedure using the discovery igs 730. the discovery igs and innova igs systems may experience x-ray abort errors during a real-time interventional procedure. this issue could potentially happen before or during fluoroscopic use and could result in the loss of imaging capability.To date, there have been no injuries reported as a result of this issue.
  • Acción
    GE Healthcare is advising that they will be in contact with affected users to arrange installation of the correction.

Device

Discovery IGS 730
  • Modelo / Serial
    Discovery IGS 730 ARTG Number: 93871(GE MEDICAL SYSTEMS, AUSTRALIA LTD X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital)
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd