Events

Retiro De Equipo (Recall) de OEC 9900 Workstation Monitor Spring Arm ScrewsAll OEC 9900 systems manufactured between October 9, 2013 and March 20, 2014, and all OEC 9900 systems that had an extension arm replaced between October 9, 2013 and March 20, 2014 are affected.

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-00389-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-02
  • 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-00389-1
  • 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 screws that attach the workstation monitor spring arm to the extension arm may fail, causing the spring arm and monitor to fall forward.
  • Acción
    A GE HealthCare Field Engineer will replace the screwS to ensure that the system is operating safely and meets all specifications. Until the correction is complete, end users are advise to use caution when positioning or extending the arm. In addition, refrain from positioning staff or patients directly underneath or in front of a work station monitor.

Device

OEC 9900 Workstation Monitor Spring Arm ScrewsAll OEC 9900 systems manufactured between October 9...
  • Modelo / Serial
    OEC 9900 Workstation Monitor Spring Arm ScrewsAll OEC 9900 systems manufactured between October 9, 2013 and March 20, 2014, and all OEC 9900 systems that had an extension arm replaced between October 9, 2013 and March 20, 2014 are affected. ARTG Number: 132698
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd