Events

Recall of Vital Images Vitrea Enterprise Suite, VitreaAdvanced, VitreaCore and Vitrea fX

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Vital Images Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    14241
  • Event Initiated Date
    2013-02-22
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    Recalling Organisation: Canon Medical Systems ANZ Pty Limited, Building 2, Level 1 Central Park, 666 Great South Road, Penrose, AUCKLAND 1051
  • Reason
    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%.
  • Action
    Software to be upgraded

Device

Vital Images Vitrea Enterprise Suite, VitreaAdvanced, VitreaCore and Vitrea fX
  • Model / 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
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    NZMMDSA