Vitrea fX & Vitrea Enterprise Suite Cl ll Vital

Company: Vital Images Inc.
Date of Enforcement Report 2/2/2011
Class ll:

PRODUCT
Vital, Vitrea fX and Vitrea Enterprise Suite fX Model number: Vitrea fX 2.1, fX 3.0, and fX 3.1 Vitrea Enterprise Suite (VES) fX 1.2 and VES fX 1.3 The Vitrea 4D CT Brain Perfusion option is intended for post processing based on dynamic CT images continuously acquired during the infection of contrast, for the visualization of apparent blood flow in brain tissue and pictorial illustration of perfusion-related parameters to aid in the assessment of the type and extent of cerebral perfusion disturbances. Recall # Z-0797-2011.

REASON
A software defect exists with Vitrea fX 2.1, 3.0 and 3.1 CT Brain Analysis whereby the annotated numeric ROI values on a batched perfusion map are incorrect when created using the auto batching function (from the right click menu) with the auto ROI templates enabled.

RECALLING FIRM/MANUFACTURER
Vital Images, Inc., Plymouth, MN, by letter dated 14 October 2010. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
182

DISTRIBUTION
Nationwide and Internationally

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020

To pre-register and get info on deep discounts or if you have questions, email training@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.