Events

Rappel de Vital, Vitrea fX and Vitrea Enterprise Suite fX

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
    57219
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0797-2011
  • Date de mise en oeuvre de l'événement
    2010-10-14
  • Date de publication de l'événement
    2010-12-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-05-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95617
  • 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 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
  • Modèle / numéro de série
    none
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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.
  • Adresse du fabricant
    Vital Images, Inc., 5850 Opus Parkway Suite 300, Plymouth MN 55343-4414
  • Société-mère du fabricant (2017)
    Canon Inc
  • Source
    USFDA