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U.S. Department of Health and Human Services

Class 2 Device Recall Vitrea CT MultiChamber Cardiac Functional Analysis application on Vitrea version 5.2

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  Class 2 Device Recall Vitrea CT MultiChamber Cardiac Functional Analysis application on Vitrea version 5.2 see related information
Date Initiated by Firm March 15, 2013
Date Posting Updated April 18, 2013
Recall Status1 Terminated 3 on February 27, 2015
Recall Number Z-1144-2013
Recall Event ID 64683
510(K)Number K052632  K043333  
Product Classification System, image processing, radiological - Product Code LLZ
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.
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

.
Recalling Firm/
Manufacturer
Vital Images, Inc.
5850 Opus Pkwy Ste 300
Minnetonka MN 55343-4411
For Additional Information Contact
952-487-9500
Manufacturer 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.
FDA Determined
Cause 2
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 fieldnotices@vitalimages.com 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = VITAL IMAGES, INC.
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