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U.S. Department of Health and Human Services

Class 2 Device Recall Vitrea

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 Class 2 Device Recall Vitrea see related information
Date Posted April 26, 2013
Recall Status1 Terminated 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
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437923
5090107572
519375
484039
5080116544
450761
5080119527
5090101981
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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
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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 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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