Events

Retiro De Equipo (Recall) de Vitrea Enterprise Suite: Vitrea, Vitrea fX and VitreaCore (Tool for analysis of diagnostic images)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por CELEO 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-00167-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-02-21
  • 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-00167-1
  • 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
    During internal testing, the manufacturer vital images has found that an error can occur when images are rotated in non-90 degree increments of the transverse/axial plane (rotation around the z-axis), while not being simultaneously rotated around the x-axis and y-axis. this orientation adjustment has been found to occur on rare occasions, such as to straighten tilts in head or neck scans, usually with minimal effect on measurements, but sometimes resulting in differences in length measurements of up to twenty nine percent and in volume measurements of up to fifty percent.
  • Acción
    Vital Images recommends that all measurements associated with the issue are verified against results from other technologies. A software patch is under development to correct the issue.

Device

Vitrea Enterprise Suite: Vitrea, Vitrea fX and VitreaCore (Tool for analysis of diagnostic images)
  • Modelo / Serial
    Vitrea Enterprise Suite: Vitrea, Vitrea fX and VitreaCore (Tool for analysis of diagnostic images)All versions prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3ARTG Number: 142791
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    CELEO Pty Ltd

Manufacturer

CELEO Pty Ltd
  • Source
    DHTGA