Events

Retiro De Equipo (Recall) de Mavig Monitor suspension arms manufactured before January 2009 (used with x-ray fluoroscopic imaging systems) Installed on INNOVA 2100, 3100 fluoroscopic imaging systems.

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-2016-RN-00003-2
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-01-04
  • 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-2016-RN-00003-2
  • 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 reported incident in which a mavig suspension arm with monitor assembly fell to the floor. the failure of spring arm rotating plate will lead to a sudden fall of the spring arm with monitors of mavig suspension. such a fall could result in bodily harm to a person. there have been no injuries reported as a result of this issue.
  • Acción
    GE Healthcare will correct all affected products. In the interim, users are advised to avoid placing the monitor over a patient, or user or other auxiliary personnel. If users observe any unusual movement or looseness of the Mavig Monitor suspension, they are advised to contact their GE Healthcare representative and follow the precautions below before continuing to use the monitor(s): 1) Position the monitor suspension in the most frequently used position and limit further movement as much as possible. 2) Clearly inform (e.g. through signage and verbal instructions) the users and other auxiliary personnel who may come in contact with the system to not move the monitor suspension once in position. GE Healthcare will send a representative to inspect the system. This action has been closed-out on 04/05/2017.

Device

Mavig Monitor suspension arms manufactured before January 2009 (used with x-ray fluoroscopic imag...
  • Modelo / Serial
    Mavig Monitor suspension arms manufactured before January 2009 (used with x-ray fluoroscopic imaging systems)Installed on INNOVA 2100, 3100 fluoroscopic imaging systems.ARTG Number: 93871
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd