Events

Rappel de Device Recall Vitrea CT MultiChamber Cardiac Functional Analysis application on Vitrea version 5.2

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
    64683
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1144-2013
  • Date de mise en oeuvre de l'événement
    2013-03-15
  • Date de publication de l'événement
    2013-04-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-02-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116766
  • 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 made a decision to perform a field correction to the vitrea ct multi-chamber cardiac functional analysis application. vital images has identified a defect in which numerical values may be incorrect in the results table under the cardiac analysis portion of the user interface.
  • Action
    Vital Images sent an Urgent Field Safety Notice dated March 15, 2013, to all affected consignees. The letter described the problem and the product affected by the recall. Letter provided a series of steps to follow which included to cease use of the device and to send the signed enclosed Effectiveness Check form to fieldnotices@vitalimages.com or fax to 1-952-540-3717. For questions customers were instructed to call Customer Support at 1-800-208-3005. For questions regarding this recall call 952-487-9500.

Device

Device Recall Vitrea CT MultiChamber Cardiac Functional Analysis application on Vitrea version 5.2
  • Modèle / numéro de série
    Serial Number EMC1112028 EMC1112027 EMC1103020 VMC1302077 VMC1202027 VMC1202028 VMC1202029 VMC1109012 MCH1006002 VMC1109008 VMC1202017 VMC1202026 VMC1202025 VMC1202032 VMC1202019 VMC1202037 VMC1202022 VMC1202023 VMC1202024 VMC1202020 VMC1202021 VMC1105013 VMC1105014 VMC1105015 VMC1109011 VMC1211048 VMC1211049 VMC1202038 VMC1211043 VMC1211044 VMC1211046 VMC1211047 VMC1211045 VMC1302064 VMC1302065 VMC1211040 VMC1302050 VMC1302051 VMC1202018 VMC1109005   VMC1302076 VMC1302075 VMC1109010 VMC1109009 VMC1202034 VMC1202031 VMC1012011 EMC1012014 EMC1012015 EMC1101016 VMC1202033 VMC1202030 EMC1203036 VMC1202015 VMC1109004 VMC1202035 VMC1111013 VMC1211041 EMC1203033 EMC1209041 EMC1203037 VMC1109006 EMC1211043 VMC1109007 EMC1211044 VMC1202039 VMC1202036 VMC1109003 VMC1211042 EMC1212047 EMC1203035 EMC1109025 EMC1203031 EMC1302049 EMC1212048 EMC1201029 EMC1212045 EMC1201030 EMC1110026 VMC1108016 EMC1107022 MCH1006011 EMC1206039 EMC1101017 MCH1006001 EMC1203034 EMC1103018 EMC1103019 EMC1107023 EMC1203032 VMC1202016 EMC1108024   EMC1209042 EMC1206038 EMC1212046 EMC1012011 VMC1201014 EMC1105021
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AR, CA, CO, IA, MI,MN, MO, NY, NC, OH, OR, PA, TX, and UT. Internationally to AUSTRIA, BELGIUM, CANADA, CHINA, COLOMBIA, GEORGIA, JAPAN, KOREA, MACEDONIA, NETHERLANDS, POLAND, PORTUGAL, RUSSIAN FEDERATION, SINGAPORE, SWEDEN, SWITZERLAND, TURKEY, UKRAINE, UNITED KINGDOM.
  • Description du dispositif
    Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 (Vitrea Enterprise Suite 1.3 and Vitrea fX 3.1) and subsequent versions of VitreaWorkstation, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite, through version 6.4. || Vitrea¿ CT Multi-Chamber Cardiac Functional Analysis provides a variety of tools for working with clinical CT images of the coronary arteries, heart, and surrounding tissue.
  • Manufacturer
    Vital Images, Inc.

Manufacturer

Vital Images, Inc.
  • Adresse du fabricant
    Vital Images, Inc., 5850 Opus Pkwy Ste 300, Minnetonka MN 55343-4411
  • Société-mère du fabricant (2017)
    Canon Inc
  • Source
    USFDA