Z-0520-2008

Vital Images ViTALConnect , Version 4.0 and 4.1, PET/CT Visualization option. Vital Images, Inc., 5850 Opus...

Name: Z-0520-2008 Vital Images ViTALConnect , Version 4.0 and 4.1, PET/CT Visualization option. Vital Images, Inc., 5850 Opus...
Creator: Vital Images, Inc.
Published: 2007-11-08
License: https://open.fda.gov/license/

Canon Medical Informatics, Inc. / initiated 2007-11-08 / Terminated / root cause: manufacturing process

FDA source

Vital Images, Inc. began a recall of 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... on 2007-11-08. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0520-2008
Status: Terminated
Initiated: 2007-11-08
Posted: 2008-01-31
Terminated: 2011-12-17
Recalling firm: Canon Medical Informatics, Inc.
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)
Product code: LLZ System, Image Processing, Radiological
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
Root cause tag: manufacturing process
FDA 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 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
Product codes and lots: Versions 4.0 and 4.1 (PET/CT Visualization option in VITALConnent)

Product code LLZ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)