Company:Vital Images, Inc.
Date of Enforcement Report 5/26//2010
Class:ll

PRODUCT
Vitrea 5.1. Vitrea fX 3.0, Vitrea Enterprise Suite 1.2 with the licensing of CT lung or CT Colon. Recall # Z-1600-2010

REASON
Vital images, Inc is issuing a recall notice on their medical device software in the use of CT Lung and CT Colon in Vitrea 5.1, Vitrea fX 3.0 or Vitre Enterprise Suite 1.2., because incorrect measurements may result.

RECALLING FIRM/MANUFACTURER
Vital Images, Inc., Plymouth, MN, by letter dated 23 February 2010. Firm initiated recall is ongoing..

VOLUME OF PRODUCT IN COMMERCE
95 units

DISTRIBUTION
Nationwide and Internationally