Events

Retiro De Equipo (Recall) de IntelePACS InteleViewer with software version 3-5-1 to 4-15-1

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-2017-RN-01234-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-09-28
  • 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-2017-RN-01234-1
  • 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
    Following a complaint from a client, intelerad is notifying users of a problem that could occur on their intelepacs software. the magnification tool functionality may display incorrect images if the user is utilising reverse ordering. in this instance, the image shown in the tool will not be the one in the current viewport. the tool may be displaying a magnified image for a different slice of the series. this software defect could lead radiologists to delay their diagnosis/report. there have been no injuries reported as a result of this issue.
  • Acción
    Emergo is advising users to be aware of this issue. A software correction will be implemented to rectify the issue.

Device

IntelePACS InteleViewer with software version 3-5-1 to 4-15-1

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia