Reported Apr 24, 2013 · Terminated
Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 (Vitrea Enterprise Suite 1.3 and…
Vital Images, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Vital Images, Inc. · 5850 Opus Pkwy Ste 300 · Minnetonka, MN · 55343-4411
Is this the product you have?
- 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.
- Lot codes and dates
- Serial Number
98 of 98 codes
EMC1112028EMC1112027EMC1103020VMC1302077VMC1202027VMC1202028VMC1202029VMC1109012MCH1006002VMC1109008VMC1202017VMC1202026VMC1202025VMC1202032VMC1202019VMC1202037VMC1202022VMC1202023VMC1202024VMC1202020VMC1202021VMC1105013VMC1105014VMC1105015VMC1109011VMC1211048VMC1211049VMC1202038VMC1211043VMC1211044VMC1211046VMC1211047VMC1211045VMC1302064VMC1302065VMC1211040VMC1302050VMC1302051VMC1202018VMC1109005VMC1302076VMC1302075VMC1109010VMC1109009VMC1202034VMC1202031VMC1012011EMC1012014EMC1012015EMC1101016VMC1202033VMC1202030EMC1203036VMC1202015VMC1109004VMC1202035VMC1111013VMC1211041EMC1203033EMC1209041
- Serial Number
- Amount recalled
- 102
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Vital Images, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.