Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version Recalled by Vital Images, Inc. Due to Vital Images has made a decision to perform...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Vital Images, Inc. directly.
Affected Products
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.
Quantity: 102
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 15 states: AL, AR, CA, CO, IA, MI, MN, MO, NY, NC, OH, OR, PA, TX, UT
About Vital Images, Inc.
Vital Images, Inc. has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report