Company: Vital Images, Inc.,
Date of Enforcement Report 2/6/2008
Class:ll

PRODUCT
Vital Images ViTALConnect, Version 4.0 and 4.1, PET/CT Visualization option. (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 # Z-0520-2008

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 update with new values for the current slice.

RECALLING FIRM/MANUFACTURER
Vital Images, Inc., Plymouth, MN, by telephone on November 7/8, 2008 and by letter November 8, 2007. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
18 units

DISTRIBUTION
Nationwide and Internationally