• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Vitrea

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Vitrea see related information
Date Initiated by Firm March 15, 2013
Date Posting Updated April 26, 2013
Recall Status1 Terminated 3 on April 08, 2015
Recall Number Z-1181-2013
Recall Event ID 64833
510(K)Number K121213  K032748  
Product Classification System, image processing, radiological - Product Code LLZ
Product Vitrea¿ CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite.

Noninvasive post-processing application designed to evaluate areas of brain perfusion.
Code Information 5080111518, 5080111291

VPE0902352, VPE0810280, VPE0906398

VPE0902369, VPE0906399, VPE0906402, VPE0906404, VPE0906407, VPE0906406, VPE0906405, VPE0906403, VPE0906395, VPE0902340, VPE0906414, VPE0906413, VPE0906410, VPE0906409, VPE0906408

, VPE0906418, VPE0906411, VPE0906401, VPE0908446, 284646, VPE1003627, VPE0906412, VPE0902361, VPE0902362, VPE0908452, VPE0908454, VPE0908451, VPE0908453, VPE0906415, VPE0810266

VPE0908455, VPE0906419, VPE0908449, VPE0902357, VPE0908464, VPE0911550

VPE1211042, VPE0810249

VPE0908471, VPE0908468, VPE0908469, VPE0906392, VPE0908470, VPE0908475, 5090111103, 5090109567, VPE0908476, 461428, 461440, VPE0908483, VPE0908486, VPE0908485, VPE0908484, 5080113111, vpe0906379, VPE0908477, VPE0707075, VPE0908448, VPE0908461, VPE0902364, VPE0902365, VPE1006710, VPE0908493, VPE0908492, VPE0906381, VPE0906385, vpe0906380, VPE0902338, VPE0906383, VPE0906396, VPE0908466, 5090112193, 338859, VPE0908488, VPE0906371, VPE0908495, VPE0908494, VPE0911536, VPE0911537, 5080114088, 339919, 5080113723, VPE0911549, 338748, 319150, VPE0911547, VPE0908490, UNK427081, 338340, VPE0906389, VPE0906387, VPE0911542, VPE0911543, VPE0911544, VPE0911552, VPE0911553, 343828, 5090104751, VPE0906382, 5080114924, VPE0908463, VPE0906394, VPE0906372, VPE0908472, 341872, VPE0609165, 5090110107, VPE0908474, 5080115106, 5080115157, VESADLCC1210039, 5080115203, VESADLCC1109027, 5080115168, VPE0911560, VPE0906391, VPE0906377, VPE0908450, VPE0911558, VPE0911538, VPE0911555, VPE0911557, vpe0906384, 5090114080, 5080121068, 5080118768, 5080119713, VPE1105788, 5080117079, 5080119195, 5090105332, 5080120576, 5090103372, 5080122951, VPE1202982, 5090106452, 474664, 5090106371, 545904, 5080121432, 5080119632, 475636, 5080120886, 5080122013, VPE1003608, 5090106940, 5080119403, 5090102082, 446718, 437923, 5090107572, 519375, 484039, 5080116544, 450761, 5080119527, 5090101981, 5090106959, 494538, 5080122617, 5090109966, VPE1006731, 5080119292, 5080117834, 5080117958, 5090103666, 5080118725, 5080118539, 438767, 5080117494, 431897, 5090111936, 554211, 5080119705, VESADLCC1012009, 5080119020, N/A, 5090106649, 5080119004, VESADLCC1201028, 5090106134, VPE0805265, 5090111111, 5090109877, 5090106630, 5090109508, 5080123273, 5080116889, 5090106576, VPE1108848, 5090106479, 5090106460, 5090109648, 5090105405, VPE0906373, VPE0906374, VPE0906376, vpe0906378, VPE0906386, VPE0906388, VPE0906390, VPE0906393, VPE0906397, VPE1202990, VPE1202975, VPE0908456, VPE0908465

VPE0908478, VPE0908479, VPE0908489, VPE0911539, VPE0911540, VPE0911541, VPE0911545, VPE1006716, VPE1006717, VPE0911548, VPE0911554, 5090102732, 5090102694, 504277, VPE0911561, VPE0911563, 5080118032, 5080116986, 5080118598, VPE0911564, 5080116781, 5080117648, 5080116692, 5090106789, 5090106797, Included, 5090108560, 5090114234, VPE1202973, 5040227256, 5080122765, 5090113491, 5080119241, VESADLCC1206035, 5090109885, 5090108676, 5090109389, 5090111928, 5090110069, 5080122374, VESADLCC1109025, 5090112754, VPE1112923, 5090103364, 360284, Included, 475637, VPE1003664, 5090103151, 351974, VPE0911569, VPE0911568, VPE0911567, VPE0911571, 372164, VPE0911565, VPE0911574, 5090112762, 353506, 5080117508, VPE0911575, VPE1003613, 355793, 464080, 355444, 359032, 355475, VPE0911579, VPE0911578, VPE0911581, VPE0911577, LTB0906007, VPE0911583, VPE1111914, VPE0911584, VPE0911585, 514726, VPE1003606, VPE1003609, VPE1003611, VPE1003610, 513852, 513840, VPE1003614, 5080117184, VESADLCC1206032, 397523, 360575, VPE0911573, 360601, 363544, 410336, 363529, 363514, 5090101973, LTB0906003, LTB0906004, LTB0906002, LTB0906005, LTB0906006, VPE1003617, VPE1003616, VPE1003618, 365214, 365126, VPE1003628, 5080118490, 372915, VPE1003621, VPE1003622, 372096, 372081, 372053, 372066, VPE1003620, VPE1003623, 372038, 372023, VPE1003626, 375819, VPE1003656, 375644, 375657, 5080117982, VPE1003679, 5090112916, VPE1003660, VPE1003669, VPE1003667, VPE1003670, VPE1003668, VPE1006707, VPE1003680, VPE1003658, VPE1003662, 5080118474

382
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, Inc. (Vital Images) received one report about potential user confusion when viewing a brain perfusion scan on Vitrea CT Brain Perfusion 2D when the scan was performed using a wide coverage shuttle acquisition technique. This may result in patient treatment delays, misdiagnosis or mistreatment.
FDA Determined
Cause 2
Labeling design
Action Consignees were sent on 3/15/2013 a VITAL Images, Inc., "Urgent Field Safety Notice" dated March 15, 2013. The letter described the problem and the product involved in the recall. The letter listed the limitations of the product and the steps to take. Consignees were requested to return the Product Recall Effectiveness Check form. Questions should be directed to Vital Images Customer Support at 1-800-208-3005 or via e-mail, support@vitalimages.com.
Quantity in Commerce 1,978
Distribution Worldwide Distribution -- USA, excluding RI and SD and including DC and PR, and the countries of ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BELARUS, BOLIVIA, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, CHANA, GREECE, GUAM, HONDURAS, HONG KONG, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN,JORDAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MEXICO, MOSCOW, MYANMAR, NAMIBIA, NETHERLANDS, NEW ZEALAND, NIGERIA, NORTHERN IRELAND, NORWAY, OMAN, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SERBIA AND MONTENEGRO, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, VIETNAM, and YEMEN.
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.
-
-