Events

Retiro De Equipo (Recall) de Software for Vitrea, Vitrea fX, and Vitrea Enterprise Suite (VES):

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Vital Images, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    63104
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0186-2013
  • Fecha de inicio del evento
    2012-08-13
  • Fecha de publicación del evento
    2012-11-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-03-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112552
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    System, image processing, radiological - Product Code LLZ
  • Causa
    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.
  • Acción
    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):
  • Modelo / Serial
    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.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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
  • Descripción del producto
    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.
  • Dirección del fabricante
    Vital Images, Inc., 5850 Opus Parkway Suite 300, Plymouth MN 55343-4414
  • Empresa matriz del fabricante (2017)
    Canon Inc
  • Source
    USFDA