Events

Rappel de Software for Vitrea, Vitrea fX, and Vitrea Enterprise Suite (VES):

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Vital Images, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    63104
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0186-2013
  • Date de mise en oeuvre de l'événement
    2012-08-13
  • Date de publication de l'événement
    2012-11-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-03-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112552
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    System, image processing, radiological - Product Code LLZ
  • Cause
    Vital images has found two potential errors in calcium score values in restored snapshots of studies generated through use of vitrea or vitrea enterprise suite. this issue affects version 3.1 of vitrea fx; version 5.2 of vitrea; versions 6.0, 6.1 and 6.2 of vitrea and vitrea fx; and versions 1.3, 6.0, 6.1 and 6.2 of vitrea enterprise suite; and all updates to those versions.
  • Action
    Vital Images sent an "URGENT DEVICE CORRECTION" letter dated August 13, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter gave advise on how to resolve the two issues and advised consignees to immediately inform all potential users. Contact Customer Support at 1-800-208-3005 for questions regarding the notice.

Device

Software for Vitrea, Vitrea fX, and Vitrea Enterprise Suite (VES):
  • Modèle / numéro de série
    Model Number Vitrea 5.2, 6.0, 6.1, and 6.2 VPMC-09346B Vitrea fX Model Number Vitrea fX 3.1, 5.2, 6.0, 6.1, and 6.2 VPMC-11731A Vitrea Enterprise Suite Model Number Vitrea Enterprise Suite 1.3, 6.0, 6.1, and 6.2.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, and the countries of ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BRAZIL, BULGARIA, CANADA CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, FINLAND, FRANCE, GREAT BRITAIN, GEORGIA, GERMANY, GHANA, GREECE, GUAM, HONDURAS, HONG KONG, INDIA, INDONESIA, IRAQ, IRELAND, ITALY, IVORY COAST, JAPAN, JORDAN KAZAKHSTAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MEXICO, MALI, MOSCOW, MYANMAR, NAMIBIA, NETHERLANDS, NEW ZEALAND, NIGERIA, NORTHERN IRELAND, NORWAY, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SENEGAL, SERBIA, SERBIA AND MONTENEGRO, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, THE NETHERLANDS, TIBET, TURKEY, UKRAINE, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, VIETNAM, AND YEMEN
  • Description du dispositif
    Software for Vitrea, Vitrea fX, and Vitrea Enterprise Suite (VES): || VPMC-09293C Vitrea . Model Number Vitrea 5.2, 6.0, 6.1, and 6.2 || VPMC-09346B Vitrea fX Model Number Vitrea fX 3.1, 5.2, 6.0, 6.1, and 6.2 || VPMC-11731A Vitrea Enterprise Suite Model Number Vitrea Enterprise Suite 1.3, 6.0, 6.1, and 6.2. || The software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional 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, DR, CR, XA, US, NM, PET, etc. The software is not meant for primary image interpretation in mammography. The Vitrea VScore option is intended for cardiac scoring from whole body CT derived measurements, including non-invasive detection and quantification of atherosclerotic plaque. Two image processing options, EKG Gate and Auto Gate, allow the operator to select images with reduced motion artifacts when processing data for Coronary Artery Calcification Scoring.
  • Manufacturer
    Vital Images, Inc.

Manufacturer

Vital Images, Inc.
  • Adresse du fabricant
    Vital Images, Inc., 5850 Opus Parkway Suite 300, Plymouth MN 55343-4414
  • Société-mère du fabricant (2017)
    Canon Inc
  • Source
    USFDA