Events

Retiro De Equipo (Recall) de INTELEVIEWER Versions 3.8.1 P355 and up (radiology picture archiving and communication 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 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-2014-RN-00292-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-03-12
  • 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-2014-RN-00292-1
  • 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
    Intelerad recently discovered a software defect where if you view reports in inteleviewer, you will not see the symbol "<" if it was used in the report. if you view reports in the ris, in intelebrowser, or in inteleconnect, you will see the proper version of the report with the "<" symbol if it was used.
  • Acción
    Emergo Australia will contact their customers to arrange for a software update as soon as the update is complete. End users are advised to view reports in the RIS, in InteleBrowser or in InteleConnect until the software problem is corrected. A customers account manager will be in contact immediately to disable to affected feature.

Device

INTELEVIEWER Versions 3.8.1 P355 and up (radiology picture archiving and communication system)

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia