Events

Retiro De Equipo (Recall) de Discovery XR656 Wall Stand System (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-2014-RN-00834-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-07-25
  • 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-00834-1
  • 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 recently become aware of two flashpad detector falls due to a broken nylon support hook. a detector fall could result in an injury to a patient or operator. there have been reported incidents of detector falls, but no injuries have been reported.
  • Acción
    Users are advised that if they observe either one of the nylon support hooks as broken or loose on the Discovery XR656 wall stand system, immediately stop use and contact their local GE Healthcare Service Representative. If the hooks are not broken, users may continue to use the wall stand system. GE Healthcare is correcting all affected systems by replacing the nylon hooks. This action has been closed-out on 03/06/2016. This action has been closed-out on 03/06/2016.

Device

Discovery XR656 Wall Stand System (X-ray system)
  • Modelo / Serial
    Discovery XR656 Wall Stand System (X-ray system)Part Numbers: 5374989 and 5397837Serial numbers: 00000100365HL6, 00000099847HL6, 00000109154HL5, 00000108716HL2, 00000109561HL1, 00000109564HL5ARTG Number: 167617
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd