Events

Retiro De Equipo (Recall) de Precision RXI X-ray Imaging Systems equipped with LCD Video Monitor LCD Video Monitor

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-00016-1
  • Clase de Riesgo del Evento
    Class II
  • 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-00016-1
  • 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 a potential safety issue involving the overhead lcd video monitor suspension. there is a potential for the locking nut to loosen out of the lcd video monitor suspension yoke. this will not lead to an immediate fall of the suspended monitor since it will be held in place by the remaining bushing and a screw in the absence of the locking-nut. to date, no injury has been reported due to this.
  • Acción
    GE Healthcare is advising users that if inappropriate performance or excessive movement of the monitor is observed to immediately contact GE Healthcare. GE Healthcare is correcting all affected systems.

Device

Precision RXI X-ray Imaging Systems equipped with LCD Video Monitor LCD Video Monitor
  • Modelo / Serial
    Precision RXI X-ray Imaging Systems equipped with LCD Video Monitor LCD Video Monitor Model Number: 2385123-2 LCD Video Monitor Serial Number: 00000001386MC2ARTG Number: 99423
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd