Vital Images, Inc. 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) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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)
Brand
Vital Images, Inc.
Lot Codes / Batch Numbers
Versions 4.0 and 4.1 (PET/CT Visualization option in VITALConnent)
Products Sold
Versions 4.0 and 4.1 (PET/CT Visualization option in VITALConnent)
Vital Images, Inc. is recalling Vital Images ViTALConnect , Version 4.0 and 4.1, PET/CT Visualization option. Vital Images, Inc., 5 due to Standard Uptake Values (SUV) display/update problems; in the way Standard Uptake Values (SUV) are displayed in 3D/MPR views. The problem arises when . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CO, FL, MI, MO, NY, PA, SC, WA, WI
Page updated: Jan 10, 2026