Events

Recall of VITREA WEB 1.1

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
    109106
  • Event Risk Class
    II
  • Event Initiated Date
    2010-09-21
  • Event Country
    Canada
  • 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
    A software defect was discovered where the fused pet and ct images do not track perfectly at all times. the error could result in an improper or delayed diagnosis and therapy decisions.

Device

VITREA WEB 1.1
  • Model / Serial
    Model Catalog: VPMC-11637 (Lot serial: vitreas enterprise suite v.1.2); Model Catalog: VPMC-11636 (Lot serial: vitreas enterprise suite v.1.2); Model Catalog: VPMC-11635 (Lot serial: vitreas enterprise suite v.1.2); Model Catalog: VPMC-11634 (Lot serial: vitreas enterprise suite v.1.2)
  • Product Description
    vitrea web
  • Manufacturer
    VITAL IMAGES INC.

Manufacturer

VITAL IMAGES INC.
  • Manufacturer Address
    MINNETONKA
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    HC