Events

Recall of Device Recall Radiological Image Processing Software

According to U.S. Food and Drug Administration, this recall involved a device in United States 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
    55222
  • Event Risk Class
    Class 2
  • Event Number
    Z-1600-2010
  • Event Initiated Date
    2010-02-23
  • Event Date Posted
    2010-05-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90352
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    system, image processing, radiological - Product Code LLZ
  • Reason
    Vital images, inc is issuing a recall notice on their medical device software in the use of ct lung and ct colon in vitrea 5.1, vitrea fx 3.0 or vitre enterprise suite 1.2. because incorrect measurements may result. questions or comments are directed to the firm's customer support at support@vitalimages.Com or at 1-800-208-3005.
  • Action
    Consignees were sent a Vital "Urgent Medical Device Software Recall Notice" letter dated 23 February 2010. The letter was addressed to "Dear Customer." The letter described the problem, product affected and provided recommendation to their customers. Questions or comments are directed to the firm's Customer Support at support@vitalimages.com or at 1-800-208-3005.

Device

Device Recall Radiological Image Processing Software
  • Model / Serial
    Vitrea 5.1. Vitrea fX 3.0, Vitrea Enterprise Suite 1.2
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AZ, AR, CA, COT, CT, FL, GA, IN, IA, KY, LA, MD, MA, MI, MN, NV, NJ, NY, ND, OH, PA, SC, TX, VA, WA, WV, WI. AUSTRALIA, SPAIN, FRANCE, BELGIUM, NETHERLANDS, PERU, NIGERIA, SWEDEN, CANADA, SWITZERLAND, EGYPT, CHINA, GERMANY, PANAMA, TAIWAN, HONG KONG, VENEZUELA, SOUTH AFRICA, CHILE, MEXICO, KOREA, COLOMBIA.
  • Product Description
    Vitrea 5.1. Vitrea fX 3.0, Vitrea Enterprise Suite 1.2 with the licensing of CT lung or CT Colon.
  • Manufacturer
    Vital Images, Inc.

Manufacturer

Vital Images, Inc.
  • Manufacturer Address
    Vital Images, Inc., 3300 Fernbrook Ln N Ste 200, Plymouth MN 55447-5370
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    USFDA