|
Class 2 Device Recall Vital Images ViTAL Connect |
|
Date Initiated by Firm |
November 08, 2007 |
Date Posted |
January 31, 2008 |
Recall Status1 |
Terminated 3 on December 17, 2011 |
Recall Number |
Z-0520-2008 |
Recall Event ID |
45820 |
510(K)Number |
K062154 K071362
|
Product Classification |
Picture Archiving and Communications System. - Product Code LLZ
|
Product |
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) |
Code Information |
Versions 4.0 and 4.1 (PET/CT Visualization option in VITALConnent) |
Recalling Firm/ Manufacturer |
Vital Images, Inc. 3300 Fernbrook Ln N Ste 200 Plymouth MN 55447-5370
|
Manufacturer Reason for Recall |
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
|
FDA Determined Cause 2 |
Process control |
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. |
Quantity in Commerce |
18 |
Distribution |
Worldwide-USA including states of SC, MO, MI, WI, NY, FL, CO, CA, PA, and WA, and countries of England and The Netherlands |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = LLZ and Original Applicant = VITAL IMAGES, INC.
|
|
|
|