Recall of VITREA2

According to Health Canada (via FOI), this recall involved a device in Canada 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
    138131
  • Event Risk Class
    II
  • Event Initiated Date
    2012-08-17
  • Event Country
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Two potential errors in calcium score values in restored snapshots of studies generated through use of vitrea or vitrea enterprise suite. these errors may lead to different treatment paths than would otherwise be followed.

Device

  • Model / Serial
    Model Catalog: VPMC-12324 (Lot serial: CONTACT MANUFACTURER); Model Catalog: VPMC-12189 (Lot serial: CONTACT MANUFACTURER); Model Catalog: VPMC-12190 (Lot serial: CONTACT MANUFACTURER); Model Catalog: VPMC-11906 (Lot serial: CONTACT MANUFACTURER); Model Catalog: VPMC-12022 (Lot serial: CONTACT MANUFACTURER); Model Catalog: VPMC-12021 (Lot serial: CONTACT MANUFACTURER); Model Catalog: VPMC-12020 (Lot serial: CONTACT MANUFACTURER); Model Catalog: VPMC-12018 (Lot serial: CONTACT MANUFACTURER); Model Catalog: VPMC-11911 (Lot serial: CONTACT MANUFACTURER); Model Catalog: VPMC-11910 (Lot serial: CONTACT MANUFACTURER); Model Catalog: VPMC-11909 (Lot serial: CONTACT MANUFACTURER); Model Catalog: VPMC-11908 (Lot serial: CONTACT MANUFACTURER); Model Catalog: VPMC-11907 (Lot serial: CONTACT MANUFACTURER); Model Catalog: VPMC-12325 (Lot serial: CONTACT MANUFACTURER); Model Catalog: VPMC-12323 (Lot serial: CONTACT MANUFACTURER); Model Catalog: VPMC-12322 (Lot serial: CONTACT MANUFACTURER); Model Catalog: VPMC-12023 (Lot
  • Product Description
    VITREA SOFTWARE APPLICATION
  • Manufacturer

Manufacturer

  • Manufacturer Address
    MINNETONKA
  • Manufacturer Parent Company (2017)
  • Source
    HC