FDA Device recall Z-1144-2013
Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 (Vitrea Enterprise Suite 1.3 and Vitrea fX 3.1) and s…
- FDA Device
- Class II
- terminated
- Published 2013-04-24
On 2013-04-24 the FDA classified a Class II recall of Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 (Vitrea Enterprise Suite 1.3 and Vitrea fX 3.1) and s… by Vital Images, citing 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 whic….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1144-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-15 |
| Published | 2013-04-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Vital Images |
| Distribution | AL, AR, CA, CO, GA, IA, MI, MN, MO, NC, NY, OH, OR, PA, TX, UT |
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.
Identifiers
| code_info | Serial Number EMC1112028 EMC1112027 EMC1103020 VMC1302077 VMC1202027 VMC1202028 VMC1202029 VMC1109012 MCH10060…Serial Number EMC1112028 EMC1112027 EMC1103020 VMC1302077 VMC1202027 VMC1202028 VMC1202029 VMC1109012 MCH1006002 VMC1109008 VMC1202017 VMC1202026 VMC1202025 VMC1202032 VMC1202019 VMC1202037 VMC1202022 VMC1202023 VMC1202024 VMC1202020 VMC1202021 VMC1105013 VMC1105014 VMC1105015 VMC1109011 VMC1211048 VMC1211049 VMC1202038 VMC1211043 VMC1211044 VMC1211046 VMC1211047 VMC1211045 VMC1302064 VMC1302065 VMC1211040 VMC1302050 VMC1302051 VMC1202018 VMC1109005 VMC1302076 VMC1302075 VMC1109010 VMC1109009 VMC1202034 VMC1202031 VMC1012011 EMC1012014 EMC1012015 EMC1101016 VMC1202033 VMC1202030 EMC1203036 VMC1202015 VMC1109004 VMC1202035 VMC1111013 VMC1211041 EMC1203033 EMC1209041 EMC1203037 VMC1109006 EMC1211043 VMC1109007 EMC1211044 VMC1202039 VMC1202036 VMC1109003 VMC1211042 EMC1212047 EMC1203035 EMC1109025 EMC1203031 EMC1302049 EMC1212048 EMC1201029 EMC1212045 EMC1201030 EMC1110026 VMC1108016 EMC1107022 MCH100601 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1144-2013%22
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