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U.S. Department of Health and Human Services

Class 2 Device Recall ACUSON Sequoia Diagnostic Ultrasound System

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 Class 2 Recall
ACUSON Sequoia Diagnostic Ultrasound System
see related information
Date Posted April 24, 2008
Recall Status1 Open
Recall Number Z-0661-2008
Recall Event ID 45410
Premarket Notification
510(K) Number
K063085 
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
Product ACUSON Sequoia Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system. Siemens Medical Solutions USA, Inc., Mountain View, CA
Code Information Material Number 8245875 with Serial Numbers: 54602 56482 55620 53997 51959 56156 56192 56040 53614 56483 56651 56526 60018 60247 60348 60835 60870 60339 56577 53519 62170 59126 62257 60258 62370 63164 54043 63929-1 55706 56104 56124 56654 56922 57303 57380 57494 59024 59131 59174 59176 59221 60054 60057 60228 60237 60251 60254 60282 60285 60338 60438 60450 60460 60461 60601 60620 60625 60631 60633 60634 60645 60647 60661 60728 60860 60875 60880 60947 61043 61053 61067 61108 61114 61118 61120 61121 61123 61127 61212 61221 61225 61290 61422 61544 61661 61673 61745 61751 61771 61974 62040 62053 62057 62116 62128 62130 62132 62233 62240 62282 62396 62431 62543 62644 62738 62764 62790 62838 62840 62861 62871 62916 62924 63023 63097 63101 63103 63114 63115 63146 63165 63184 63196 63203 63205 63208 63337 63366 63368 63389 63408 63420 63455 63462 63468 63470 63566 63573 63690 63856 63862 63867 63878 63885 63886 63899 63928 64051 50970 51577 52356 52448 52565 52732 52743 52770 53437 53712 53725 54223 54549 54937 55091 55092 55156 55272 55734 54640 55197 53060 54446 54254 54423 54766 52071 52110 52427 53011 55012 54686 51080 52076 53357 54552 53467 54380 54688 52959 53932 52034 54121 52051 53446 50447 50834 50975 51048 51073 51571 52865 53252 53626 53631 53643 53844 53950 54065 54123 54317 54389 54521 54529 54546 54603 54934 54949 55082 55104 55135 55140 55441 55461 55838 55895 56355 57017 55351 55244 54315 54199 54366 51648 53978 51023 54489 54536 54808 50140 54130 53579 55553 50194 55853 53590 55477 53524 54958 63546 56823 56717 56758 56786 56196 55713 56123 56247 56248 56625 62755 50235 54425 53244 53803 50228 53182 54361 and 53990 Material Number 8246951with Serial Numbers: 62519 62835 63108 56191 and 54332 Material Number 8267697 with Serial Numbers: 63168 61316 62848 63188 63275 and 63727
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc.
1230 Shorebire Way
P.O. Box 7393
Mountain View, California 94043
Manufacturer Reason
for Recall
Measurement Error affecting all Sequoia systems using the PAL video standard configuration and have a perspective PC installed: 1) The Sequoia" system is operating at a software revision below 8.0. 2) The Sequoia" system is configured to PAL video mode (normal for systems running at 240V 50 Hz.). 3) While using any of the Perspective" advanced display options listed above, an image or clip is t
FDA Determined
Cause 2
DESIGN: Software Design
Action Consignees were notified via a Urgent Medical Device Notification letter/customer letter sent out on 9/25/2007 under Siemens update program US013/07/S. The Siemens Service organization coordinates the implementation of the field correction with the distributors for all countries. Consignees who do not respond to the recall communication will be visit ed and/or telephoned for follow up.
Quantity in Commerce 280
Distribution Worldwide Distribution including the countries of: Australia, Austria, Belgium, Brazil, Brunei, China, Denmark, Finland, France, Germany, Great Britain (UK), Greece, Hungary, India, Iran, Ireland, Italy, Latvia, Netherlands, New Zealand, Romania, Russian Federation, Singapore, Spain, Switzerland, Thailand. U.S customers were not affected.
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 = IYN and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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