Events

Retiro De Equipo (Recall) de Device Recall Vital Connect

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
    56923
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1021-2011
  • Fecha de inicio del evento
    2010-08-23
  • Fecha de publicación del evento
    2011-02-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-11-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94929
  • 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
    There is a potential alignment error of fused pet/ct images in the vitrea core component of vitrea enterprise suite 1.2 and 1.3. the error occurs during panning of the fused pet/ct images. because the pet data has a larger voxel size than the ct data, it is possible to pan the ct image in more frequent, smaller steps than the pet image, so that the fused pet image does not move until the ct data.
  • Acción
    The firm, Vital Images, Inc,., sent a "Urgent Software Alert" letter dated August 23, 2010 to all customers. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to not use the PET/CT fusion functionality until the software updates are provided and to re-examine any past results. If you have any questions or comments, contact Customer Support at support@vitalimages.com or at 1-800-208-3005.

Device

Device Recall Vital Connect
  • Modelo / Serial
    Any VitalConnect version, or the Vitrea Core component of Vitrea Enterprise Suite (VES) 1.2 adn VES 1.3.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA including states of: AK, AZ, CA, CO, CT, FL, GA, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MS, MO, NH, NJ, NM, NY, NC, ND, OH, PA, SC, TN, TX VA, WV, WI, and WY; and countries of: AUSTRALIA, HONG KONG, UNITED KINGDOM, NETHERLANDS, FRANCE, BELGIUM, CANADA, CHINA, AUSTRALIA, SWITZERLAND, and ITALY.AUSTRALIA, HONG KONG, UNITED KINGDOM, NETHERLANDS, FRANCE, BELGIUM, CANADA, CHINA, AUSTRALIA, SWITZERLAND, ITALY.
  • Descripción del producto
    Vital Connect 4.0 & 4.1, radiological image processing software || A Medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a variety of imaging devices including: CT MR, CR/DR/DX, SC, US, NM, PET, XA and RF, etc. Vital connect has the following intended use: Vessel Probe is intended for viewing the anatomy and pathology of a patient's coronary arteries. Clinicians select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotate-able curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel.
  • 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