Events

Recall of Vital, Vitrea fX and Vitrea Enterprise Suite fX

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
    57219
  • Event Risk Class
    Class 2
  • Event Number
    Z-0797-2011
  • Event Initiated Date
    2010-10-14
  • Event Date Posted
    2010-12-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95617
  • 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., reported that a software defect exists with vitrea fx 2.1, 3.0 and 3.1 ct brain analysis whereby the annotated numeric roi values on a batched perfusion map are incorrect when created using the auto batching function (from the right click menu) with the auto roi templates enabled.
  • Action
    Vital Images, Inc sent a Vital "Urgent Software Update Alert" letter dated 14 October 2010 to all Consignees/Customers. The letter described the product and problem. They advised, until new software is installed, that the customers can avoid obtaining incorrect values by tuning off ROI templates prior to selecting the batch option from the right click menu in the CT Brain Analysis application; and recommended that the customers re-examine any ROI perfusion values that were previously generated using automatic collage batching with ROI templates. Please direct any questions or comments to Customer Support at support@vitalimages.com or at 1-800-208-3005. Any help needed to install this software update can also be directed to Customer Support.

Device

Vital, Vitrea fX and Vitrea Enterprise Suite fX
  • Model / Serial
    none
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including states of: AL, AZ, AR, CA, CO, FL, GA, IA, KY, LA, MD, MA, MI, MN, MO, MT, NY, NJ, ND, OH, PA, PR, TN, TX, WA, WI, and WY, and countries of: CANADA, NETHERLANDS, TAIWAN, CHINA, SINGAPORE, UNITED KINGDOM, BRAZIL, GERMANY, RUSSIA, THAILAND, FRANCE, REPUBLIC OF KOREA, SPAIN, PAKISTAN,IRELAND, JAPAN, AUSTRALIA, INDIA, CZECH REPUBLIC, HONG KONG, EGYPT, ITALY, AUSTRIA, SLOVAK IA, BULGARIA, LEBANON, ALGERA, TAIWAN, SOUTH ARICA, BELGIUM, MALAYSIA, DENMARK, and JORDAN.CANADA, NETHERLANDS, TAIWAN, CHINA, SINGAPORE, UNITED KINGDOM, BRAZIL, GERMANY, RUSSIA, THAILAND, FRANCE, REPUBLIC OF KOREA, SPAIN, PAKISTAN,IRELAND, JAPAN, AUSTRALIA, INDIA, CZECH REPUBLIC, HONG KONG, EGYPT, ITALY, AUSTRIA, SLOVAK IA, BULGARIA, LEBANON, ALGERA, TAIWAN, SOUTH ARICA, BELGIUM, MALAYSIA, DENMARK, JORDAN.
  • Product Description
    Vital, Vitrea fX and Vitrea Enterprise Suite fX || Model number: Vitrea fX 2.1, fX 3.0, and fX 3.1 || Vitrea Enterprise Suite (VES) fX 1.2 and VES fX 1.3 || The Vitrea 4D CT Brain Perfusion option is intended for post processing based on dynamic CT images continuously acquired during the infection of contrast, for the visualization of apparent blood flow in brain tissue and pictorial illustration of perfusion-related parameters to aid in the assessment of the type and extent of cerebral perfusion disturbances.
  • Manufacturer
    Vital Images, Inc.

Manufacturer

Vital Images, Inc.
  • Manufacturer Address
    Vital Images, Inc., 5850 Opus Parkway Suite 300, Plymouth MN 55343-4414
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    USFDA