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

FDA Device Recall #Z-1144-2013 — Class II — March 15, 2013

Recall Summary

Recall Number Z-1144-2013
Classification Class II — Moderate risk
Date Initiated March 15, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Vital Images, Inc.
Location Minnetonka, MN
Product Type Devices
Quantity 102

Product Description

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.

Distribution Pattern

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.

Lot / Code Information

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

Other Recalls from Vital Images, Inc.

Recall # Classification Product Date
Z-0169-2014 Class II VitreaCore¿ software. Versions subject to the l... Oct 21, 2013
Z-1181-2013 Class II Vitrea¿ CT Brain Perfusion made available in va... Mar 15, 2013
Z-1002-2013 Class II Vitrea Enterprise Suite, Vitrea, VitreaAdvanced... Feb 5, 2013
Z-0186-2013 Class II Software for Vitrea, Vitrea fX, and Vitrea En... Aug 13, 2012

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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