Events

Retiro De Equipo (Recall) de Vital Images Vitrea Enterprise Suite, VitreaAdvanced, VitreaCore and Vitrea fX

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Vital Images Inc.

¿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
    14241
  • Fecha de inicio del evento
    2013-02-22
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Canon Medical Systems ANZ Pty Limited, Building 2, Level 1 Central Park, 666 Great South Road, Penrose, AUCKLAND 1051
  • Causa
    Manufacturer has found an error regarding measurement. this error occurs when images are rotated at the time of reconstruction by the scanner in non-90 degree increments of the transverse/xial plane (rotation around the z-axis), while not being simultaenously rotated around the x-axis and y-axis. manufacturer has found that this orientation adjustement to occur on rare occasions, such as to straighten tilts in head or neck scans, sually with minimal efect on measurements, but sometimes resulting in differences in mength measurement of up to 29% and in volume measurements of up to 50%.
  • Acción
    Software to be upgraded

Device

Vital Images Vitrea Enterprise Suite, VitreaAdvanced, VitreaCore and Vitrea fX
  • Modelo / Serial
    Model: , Affected: prior to version 6.3.3 except 6.1.6, 6.2.3 and 6.3
  • Manufacturer
    Vital Images Inc

Manufacturer

Vital Images Inc
  • Empresa matriz del fabricante (2017)
    Canon Inc
  • Source
    NZMMDSA