Events

Recall of Vital Images VitreaCore Software

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
    16007
  • Event Initiated Date
    2014-01-21
  • 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
    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.
  • Action
    Software to be upgraded

Device

Vital Images VitreaCore Software
  • Model / 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
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    NZMMDSA