Recall Z-1144-2013— Vital Images, Inc.

Name: FDA recall Z-1144-2013
Creator: U.S. Food and Drug Administration
Published: 2013-03-15

Class II · Terminated

Class II FDA medical device recall by Vital Images, Inc., initiated 2013-03-15, terminated 2015-02-27. It names 2 FDA 510(k) clearances: K052632, K043333. Product: Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 (Vitrea Enterprise Suite 1.3 and Vitrea fX 3.1) and subsequent versions of VitreaWorkstation, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite, through version 6.4. Vitrea¿ CT Multi-Chamber Cardiac Functional Analysis provides a variety of tools for working with clinical CT images of the coronary arteries, heart, and surrounding tissue.. Reason: Vital Images has made a decision to perform a field correction to the Vitrea CT Multi-Chamber Cardiac Functional Analysis application. Vital Images has identified a defect in which numerical values may be incorrect in the Results Table under the Cardiac Analysis portion of the user interface..

Recalling firm: Vital Images, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-03-15
Terminated: 2015-02-27
Firm location: Minnetonka, MN, United States

510(k) clearances named in this recall

2 on FDA's record

K052632 — VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWAREVital Images, Inc.·cleared 2005-12-15
K043333 — VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEMVital Images, Inc.·cleared 2004-12-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 (Vitrea Enterprise Suite 1.3 and Vitrea fX 3.1) and subsequent versions of VitreaWorkstation, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite, through version 6.4. Vitrea¿ CT Multi-Chamber Cardiac Functional Analysis provides a variety of tools for working with clinical CT images of the coronary arteries, heart, and surrounding tissue.

Reason for recall

Vital Images has made a decision to perform a field correction to the Vitrea CT Multi-Chamber Cardiac Functional Analysis application. Vital Images has identified a defect in which numerical values may be incorrect in the Results Table under the Cardiac Analysis portion of the user interface.

Data sourced from openFDA. This site is unofficial and independent of the FDA.