Z-1144-2013Class II

Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 (Vitrea Enterprise...

Name: Z-1144-2013 Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 (Vitrea Enterprise...
Creator: Vital Images, Inc.
Published: 2013-03-15
License: https://open.fda.gov/license/

Canon Medical Informatics, Inc. / initiated 2013-03-15 / Terminated / root cause: software

FDA source

Vital Images, Inc. began a 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 subsequent versions... on 2013-03-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1144-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-15
Posted: 2013-04-18
Terminated: 2015-02-27
Recalling firm: Canon Medical Informatics, Inc.
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.
Product code: LLZ System, Image Processing, Radiological
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.
Root cause tag: software
FDA root cause: Software design
Action: Vital Images sent an Urgent Field Safety Notice dated March 15, 2013, to all affected consignees. The letter described the problem and the product affected by the recall. Letter provided a series of steps to follow which included to cease use of the device and to send the signed enclosed Effectiveness Check form to [email protected] or fax to 1-952-540-3717. For questions customers were instructed to call Customer Support at 1-800-208-3005. For questions regarding this recall call 952-487-9500.
Quantity in commerce: 102
Distribution: Worldwide Distribution - USA including AL, AR, CA, CO, IA, MI,MN, MO, NY, NC, OH, OR, PA, TX, and UT. Internationally to AUSTRIA, BELGIUM, CANADA, CHINA, COLOMBIA, GEORGIA, JAPAN, KOREA, MACEDONIA, NETHERLANDS, POLAND, PORTUGAL, RUSSIAN FEDERATION, SINGAPORE, SWEDEN, SWITZERLAND, TURKEY, UKRAINE, UNITED KINGDOM.
Product codes and lots: 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 MCH1006011 EMC1206039 EMC1101017 MCH1006001 EMC1203034 EMC1103018 EMC1103019 EMC1107023 EMC1203032 VMC1202016 EMC1108024 EMC1209042 EMC1206038 EMC1212046 EMC1012011 VMC1201014 EMC1105021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1144-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1144-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-18

Product code LLZ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)