Events

Recall of Device Recall Vital Images 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
    45820
  • Event Risk Class
    Class 2
  • Event Number
    Z-0520-2008
  • Event Initiated Date
    2007-11-08
  • Event Date Posted
    2008-01-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66214
  • 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
    Picture Archiving and Communications System. - Product Code LLZ
  • Reason
    Standard uptake values (suv) display/update problems; in the way standard uptake values (suv) are displayed in 3d/mpr views. the problem arises when a user draws a selected region of interest in order to calculate the suv statistics of the region. if the user then changes the slice shown by scrolling through additional slices, the original suv measurements will remain on the screen and do not up.
  • Action
    Customers were notified via telephone (11/7 -11/8/2007) and issued an Urgent Medical Device recall notification letter on 11/8/07. The letter described the problem and product involved. The letter also informed customers they they will provide a free software patch within the next 6-8 weeks.

Device

Device Recall Vital Images ViTAL Connect
  • Model / Serial
    Versions 4.0 and 4.1 (PET/CT Visualization option in VITALConnent)
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide-USA including states of SC, MO, MI, WI, NY, FL, CO, CA, PA, and WA, and countries of England and The Netherlands
  • Product Description
    Vital Images ViTALConnect , Version 4.0 and 4.1, PET/CT Visualization option. Vital Images, Inc., 5850 Opus Parkway, Suite 300, Minnetonka, MN 55343. ( A web-based medical diagnostic tool that allows physicians to use PCs or notebook computers to gain remote access to 2D, 3D, and 4D advanced visualization. The software enables users to measure, rotate, and analyze images)
  • Manufacturer
    Vital Images, Inc.

Manufacturer

Vital Images, Inc.
  • Manufacturer Address
    Vital Images, Inc., 3300 Fernbrook Ln N Ste 200, Plymouth MN 55447-5370
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    USFDA