Events

Recall of Device Recall Vital Connect

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Vital Images, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    56923
  • Event Risk Class
    Class 2
  • Event Number
    Z-1021-2011
  • Event Initiated Date
    2010-08-23
  • Event Date Posted
    2011-02-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94929
  • Notes / Alerts
    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.
  • Extra notes in the data
    System, image processing, radiological - Product Code LLZ
  • Reason
    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.
  • Action
    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
  • Model / Serial
    Any VitalConnect version, or the Vitrea Core component of Vitrea Enterprise Suite (VES) 1.2 adn VES 1.3.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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.
  • Manufacturer Address
    Vital Images, Inc., 5850 Opus Parkway Suite 300, Plymouth MN 55343-4414
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    USFDA