Events

Retiro De Equipo (Recall) de FlexiView 8800 Mobile C-Arms (Mobile, general-purpose, diagnostic, fluoroscopic x-ray 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-2012-RN-01112-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-10-31
  • 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-2012-RN-01112-1
  • 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 surgery has finalised the corrections to remedy the issues communicated to the customers in 2006 and 2007 (tga recall reference #rn-2007-0077) . specifically, these corrections will address issues involving system lock-ups,incorrect image display, system stalls during the boot cycle, and failure of the system to display the air kerma and cumulative air kerma.
  • Acción
    GE Healthcare is providing work around instructions to mitigate the risk and will be implementing a software update to permanently correct the issue.

Device

FlexiView 8800 Mobile C-Arms (Mobile, general-purpose, diagnostic, fluoroscopic x-ray system)
  • Modelo / Serial
    FlexiView 8800 Mobile C-Arms (Mobile, general-purpose, diagnostic, fluoroscopic x-ray system) ARTG Number: 92396
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd