Events

Retiro De Equipo (Recall) de Discovery MR450, MR750 and Optima MR450w MRI 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-2013-RN-00885-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-08-19
  • 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-2013-RN-00885-1
  • 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 due to exposed yellow foam on the end bells of discovery mr450, mr750 and optima mr450w product. the yellow foam strip used between the end bell covers and patient bore of certain ge mr products may extend past the surface of the covers. the foam itself is not hazardous. however, any fluid or body substance absorbed by the extended foam may come into contact with patients and act as a fomite potentially transferring infectious agents from one patient to another.
  • Acción
    GE Healthcare is advising users that the system may continue to be used as normal even with the yellow foam protruding from the bore. Patient padding should be used as described in the Operating manuals and cleaning practices described in the Operating manuals should be followed. Patient padding will minimise contact with the foam and users are advised not to attempt to remove the foam. GE Healthcare will be installing a permanent cover over the foam in October 2013.

Device

Discovery MR450, MR750 and Optima MR450w MRI System

Manufacturer

GE Healthcare Australia Pty Ltd