Company:Vital Images, Inc.
Date of Enforcement Report 2/22/12
Class ll:

PRODUCT
Vitrea (available in various configuration as Vitrea Enterprise Suite). Vitrea Enterprise Suite 1.2, Vitrea Enterprise Suite 1.3, Vitrea enterprise Suite 6.0 and Vitrea Enterprise Suite 6.1. A medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from variety of imaging devices. Recall # Z-0388-2012

REASON
Vital Images has found two issues that may display incorrect Standard Update Values (SUV) when viewing certain PET/CT images. This issue affects the VitreaCore PET/CT feature for Vitrea Enterprise Suite 1.2, 1.3, 6.0, 6.1, including all updates to those versions.

RECALLING FIRM/MANUFACTURER
Vital Images, Inc., Plymouth, MN, by letter dated November 11, 2011. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
338 (233 US)

DISTRIBUTION
Nationwide and Internationally