Vitrea CT Multi-Chamber Cardiac Functional Analysis application on… — Class II medical device recall Z-1144-2013
Terminated recall by Vital Images, Inc., reported 2013-04-24, distributed in AL, AR, CA, CO, GA, IA, MI, MN…. Vital Images has made a decision to perform a field correction to the Vitrea CT Multi-Chamber Cardiac Function
| Recall number | Z-1144-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vital Images, Inc., Minnetonka, MN, United States |
| Recall initiated | 2013-03-15 |
| Classified | 2013-04-18 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2015-02-27 |
| Distributed | AL, AR, CA, CO, GA, IA, MI, MN, MO, NC, NY, OH, OR, PA, TX, UT |
| Countries outside the US | AT, BE, CA, CH, CN, CO, GB, JP, KR, NL, PL, PT, SE, SG, TR, UA |
| Quantity | 102 |
| Serial numbers | EMC1012011, EMC1012014, EMC1012015, EMC1101016, EMC1101017, EMC1103018, EMC1103019, EMC1103020, EMC1105021, EMC1107022, EMC1107023, EMC1108024, EMC1109025, EMC1110026, EMC1112027, EMC1112028, EMC1201029, EMC1201030, EMC1203031, EMC1203032, EMC1203033, EMC1203034, EMC1203035, EMC1203036, EMC1203037 and 73 more |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1144-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.