Events

Retiro De Equipo (Recall) de 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant MR Systems (Magnetic Resonance 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-2013-RN-00454-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-05-16
  • 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-00454-1
  • 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
    For clariview and screen save from gems visualisation toolkit viewer, the mr product can generate image headers with non-unique series identifiers, which when exported to some pacs systems, results in the series being associated with the incorrect study on the pacs. the intended study will not have the correct series listed and an unintended study will have it listed instead. patient identifying annotation remains correct. note that related issues have only been seen on pacs systems manufactured by intelerad (intelepacs 4-3-1-p350 and intelebrowser -4-3-1-p350) at this time.
  • Acción
    GE Healthcare is providing temporary work around instructions and implementing a software update to correct the issue.

Device

1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant MR Systems (Magnetic Resonance Imaging Systems)
  • Modelo / Serial
    1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant MR Systems (Magnetic Resonance Imaging Systems)ARTG Number: 108415
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd