Events

Retiro De Equipo (Recall) de IntelePACS InteleViewer software 4-10-1 and earlier versions (Picture archiving and communication system for radiology)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

¿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-01045-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-08-11
  • 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-01045-1
  • 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 image fusion functionality may display an incorrect calculation of standard uptake value (suv) when loading the presentation state of image for a previously calculated (and saved) region of interest (roi). this software defect could lead radiologists to base their diagnosis/report on erroneous anatomical measurement leading to incorrect medical treatment.To date, there have been no reports of patient incidents.
  • Acción
    Emergo is advising users to confirm the software version installed on their IntelePACS system and if the version is 4-10-1 or earlier, to authorise Intelerad to install an upgrade to InteleViewer 4-11-1 or later. Users are advised to stop using the presentation states functionality of the Image Fusion module until they have InteleViewer 4-11-1 or later installed on their workstation. This action has been closed-out on 02/03/2017.

Device

IntelePACS InteleViewer software 4-10-1 and earlier versions (Picture archiving and communication...

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia