Events

Retiro De Equipo (Recall) de Vital Images VitreaCore Software

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
    16007
  • Fecha de inicio del evento
    2014-01-21
  • 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
    Risk of patient misdiagnosis or inappropriate treatment due to incorrect image orientation marking., this may occur when loading a study into the 3d viewer in vitreacore, taking a 16-bit secondary capture snapshot of the study and loading this snapshot in a dicom viewer., vital images has provided advice on how to confirm that snapshots are correctly marked.
  • Acción
    Software to be upgraded

Device

Vital Images VitreaCore Software
  • Modelo / Serial
    Model: , Affected: , Software version: Versions 6.0 to 6.5 inclusive, including all upgrades (except 6.3.1, 6.4.4 and 6.4.5)
  • Manufacturer
    Vital Images Inc

Manufacturer

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