Events

Retiro De Equipo (Recall) de GSI Viewer, prior to version 2.00-0M on AW and prior to version 2.20-0B in AW Server (Picture archiving and communication system, PACS)

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-01077-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-10-17
  • 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-01077-1
  • 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 gsi viewer application running on aw/volume share or on the aw server when making a batch and rotating the batch group clockwise 180 degrees (inferior to superior) will display images in the superior orientation. the orientation annotation on the image is correct. the concern is that the patient right/left representation is from the superior view, which could result in a misreading of the image and misdiagnosis.
  • Acción
    GE Healthcare is advising users that the orientation annotation is correct on the image, and to always correlate any information in any 3D reconstruction with the original data. GE Healthcare advises that a software correction will be installed on all affected systems by March 2014.

Device

GSI Viewer, prior to version 2.00-0M on AW and prior to version 2.20-0B in AW Server (Picture arc...
  • Modelo / Serial
    GSI Viewer, prior to version 2.00-0M on AW and prior to version 2.20-0B in AW Server (Picture archiving and communication system, PACS)ARTG Number: 161257
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd