Events

Recall of Vital Images Vitrea imaging 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
    14809
  • Event Initiated Date
    2014-09-30
  • 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: Des N Barnes, 313 Ararimu Road, Ramarama, Auckland 1750
  • Reason
    Risk of patient misdiagnosis, inappropriate treatment or treatment delay due to incompatibility of software with certain protocols or ct units., analysis of data in vitrea ct brain perfusion 2d may lead to inaccurate perfusion maps if the data is acquired by an unsupported ct scanner.
  • Action
    Software to be upgraded

Device

Vital Images Vitrea imaging software

Manufacturer

Vital Images Inc
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    NZMMDSA