Recall Z-0520-2008 ยท LLZ System, Image Processing, Radiological
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)
| Date | Jan 31, 2008 (initiated Nov 8, 2007) |
| Status | Terminated |
| 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 |
| Root cause | 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 | 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 |
| FDA record | Open on fda.gov |