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U.S. Department of Health and Human Services

Class 2 Device Recall Vitrea

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 Class 2 Recall
Vitrea
see related information
Date Posted January 11, 2012
Recall Status1 Terminated on December 03, 2013
Recall Number Z-0388-2012
Recall Event ID 60418
Premarket Notification
510(K) Numbers
K061624  K071331 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Vitrea (available in various configuration as Vitrea Enterprise Suite). Vitrea Enterprise Suite 1.2, Vitrea Enterprise Suite 1.3, Vitrea enterprise Suite 6.0 and Vitrea Enterprise Suite 6.1. A medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from variety of imaging devices.
Code Information Vital ID 10013 10079 10082 10092 10099 10104 10112 10117 10126 10127 10141 10149 10150 10158 10161 10174 10186 10199 10200 10210 10224 10225 10226 10227 10236 10250 10276 10300 10305 10306 10327 10351 10355 10359 10364 10380 10394 10395 10396 10400 10409 10412 10413 10415 10416 10418 10432 10437 10478 10487 10491 10499 10533 10539 10574 10575 10592 10607 10610 10613 10633 10635 10637 10656 10664 10665 10671 10685 10691 10697 10698 10709 10729 10732 10737 10739 10741 10748 10753 10767 10796 10798 10800 10802 10806 10827 10834 10859 10870 10878 10879 10880 10898 10921 10968 10991 11033 11088 11093 11119 11129 11136 11150 11165 11168 11178 11185 11233 11235 11252 11260 11262 11263 11269 11271 11280 11287 11289 11310 11316 11333 11342 11359 11366 11401 11404 11412 11444 11483 11513 11544 11555 11597 11613 11623 11684 11696 11776 11827 11888 11922 11941 11991 12043 12118 12122 12226 27622 27658 27674 27694 27729 27766 27774 27833 27849 27879 27889 27893 27908 27933 27958 27992 27994 28041 28076 28179 28194 28228 28236 28243 28263 28356 28405 28455 28470 28510 28516 28547 28552 28559 28567 28582 28603 28667 28668 28716 28724 28746 28808 28882 28914 28915 28917 28920 28921 28939 28956 28958 29007 29009 29010 29017 29024 29025 29026 29087 29088 29097 29154 29155 29156 29157 29158 29167 29229 29271 29281 29290 29340 29341 29351 29372 29373 29375 29376 29507 29546 29551 29557 29569 29570 29573 29574 29583 29586 29601 29603 29606 29607 29609 29610 29623 40108 40117 40131 40163 40176 40192 40284 40295 40325 40513 40565 40614 40617 40647 40706 40714 40722 40739 40771 40926 41109 41145 41194 41230 41256 41439 41461 41507 41539 41596 41674 41981 42093 42153 42521 42873 42934 43369 43503 43536 43557 43635 43669 43720 45759 45960 46274 46672 47454 47920 48344 52042 52976 53018 53025 53033 53055 53117 53175 53194 53196 53197 53443 53535 53537 53544 53672 53673 53744 53745 53748 53897 53898 54012 54022 54102 54318 54821 54822 54827 54830 54863 54945 55005 55008 55063 55302 55327 55375 55901 56015 56185 57343 28591 40391
Recalling Firm/
Manufacturer
Vital Images, Inc.
5850 Opus Parkway Suite 300
Plymouth, Minnesota 55343-4414
Manufacturer Reason
for Recall
Vital Images has found two issues that may display incorrect Standard Update Values (SUV) when viewing certain PET/CT images. This issue affects the VitreaCore PET/CT feature for Vitrea Enterprise Suite 1.2, 1.3, 6.0, 6.1, including all updates to those versions.
FDA Determined
Cause 2
DESIGN: Software Design
Action Vital Images, Inc. sent an URGENT DEVICE RECALL letter dated November 11, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to inform all potential users of the issues. Customers were to be contacted by their Service Account Manager to discuss and schedule resolutions. For questions customers were to contact Vital Images Customer Support with any questions toll free at 1-800-208-3005, in Europe +31 (0) 70 4135801, in Asia t +86 10 8588 1800, or online at support@vitalimages.com.
Quantity in Commerce 338 (233 US)
Distribution Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, ND, OH, OK OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY and the countries of IRELAND, FRANCE, UNITED KINGDOM, SWITZERLAND, AUSTRALIA, SLOVENIA, GERMANY, NETHERLANDS, BELGIUM, PAKISTAN, BRAZIL, ARGENTINA, SWEDEN, QATAR, CHINA, FINLAND, ITALY, DENMARK, PORTUGAL, REPUBLIC OF KOREA, SPAIN, and CANADA
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = VITAL IMAGES, INC.
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