Events

Retiro De Equipo (Recall) de Vital, Vitrea fX and Vitrea Enterprise Suite fX

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
    57219
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0797-2011
  • Fecha de inicio del evento
    2010-10-14
  • Fecha de publicación del evento
    2010-12-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95617
  • 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 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.
  • Acción
    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
  • Modelo / Serial
    none
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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.
  • Dirección del fabricante
    Vital Images, Inc., 5850 Opus Parkway Suite 300, Plymouth MN 55343-4414
  • Empresa matriz del fabricante (2017)
    Canon Inc
  • Source
    USFDA