Events

Recall of Device Recall Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to ve

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
    64461
  • Event Risk Class
    Class 2
  • Event Number
    Z-1002-2013
  • Event Initiated Date
    2013-02-05
  • Event Date Posted
    2013-03-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116182
  • 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 has found a potential error in measurement generated through the software which affects all versions of vitrea enterprise suite, vitrea, vitreaadvanced, vitreacore (vitalconnect) and vitrea fx prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3. this error occurs when images are rotated at the time of reconstruction by the scanner in non-90 degree increments of the transverse/axia.
  • Action
    Vital Images sent an "Urgent Field Safety Notice' letter dated February 5, 2013, to all affected customers. The letter identified the probelm the product and the action needed to be taken by the customer. Please immediately inform all potential users of Vitrea of the information contained in this letter. We recommend that all measurements associated with the error described in this letter be verified against results from other technologies. You will be contacted by Vital Images Customer Support or by the customer support department of your distributor to arrange for installation of this patch on your system. We recommend that you implement the patch. If you have an earlier version, Vital Images Customer Support or your distributor will contact you to discuss your options for replacement. Please sign this Notice in the space below to verify that you have received and understood it, and return your signed Notice by email to fieldnotices@vitalimages.com. If you have questions, direct customers of Vital Images should contact Vital Images Customer Support at 1-800-208-3005 or by e-mail to support@vitalimages.com; customers through a distributor of Vital Images products should contact that distributor. Updated 5/28/2013: A second consignee Vital Images, Inc "Urgent Field safety Notice" letter dated March 26, 2013 was sent to consignees on 3/25/13. The follow-up letter was sent via e-mail and mail to 4,616 already-notified consginees, who had received affected versions 6.3.0, 6.2.3, or 6.1.6. The letter described the problem and the affected product being recalled and provided a number of steps to follow which included to retun the Effectiveness Check form.

Device

Device Recall Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vit...
  • Model / Serial
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - All states in continental USA including DC, PR and the countries of ALGERIA, ARGENTINA, ANGOLA, ARMENIA, AUSTRALIA, AUSTRIA, BENGLADESH, BELARUS, BELGIUM, BOLIVIA, BOTSWANA, BRAZIL BULAGARIA, CAMBODIA, CANADA, CENTRAL AFRICAN REPUBLIC, CHAD, CHILE, CHINA , COLOMBIA, CONGO, CROATIA, CYRPRUS, CZECH REPUBLIC, DENMARK, DJIBOUTI, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GREAT BRITAIN, GEORGIA, GERMANY, GHANA, GREECE, GUAM, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, IVORY COAST, JAPAN, JORDAN, KAZAKHASTAN, KOREA, LEBANON, LITHUANIA, MACEDONIA, MALYASIA, MALI, MAURITIUS, MEXICO, MALDOVA, MOSCOW, NYNMAR, NAMBIA, NAMIRGIA, NEPAL, NETHERLANDS, NEW ZEALAND, NIGER, NIGERIA, NORTHERN IRELAND, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILLIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, RUSSIAN FEDERATION, SAUDI ARABIA, SENEGAL, SERBIA, SEBIA AND MONROBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOMALIA, SOUTH AFRICA, SPAIN, SRI LANKA, SUDAN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, THE NETHERLANDS, TIBET, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBERKISTAN, VENEZUELA, VIETNAM and YEMEN.
  • Product Description
    Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3 || The software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multidimensional digital images acquired from a variety of imaging devices. It provides the ability to review digital images from original DICOM data for multiple modalities, including CT, MR, D, CR, XA, US, NM, PET, etc. The software is not meant for primary image interpretation in mammography.
  • Manufacturer
    Vital Images, Inc.

Manufacturer

Vital Images, Inc.
  • Manufacturer Address
    Vital Images, Inc., 5850 Opus Pkwy Ste 300, Minnetonka MN 55343-4411
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    USFDA