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U.S. Department of Health and Human Services

Class 2 Device Recall Vital Images ViTAL Connect

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  Class 2 Device Recall Vital Images ViTAL Connect see related information
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.
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