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U.S. Department of Health and Human Services

Class 2 Device Recall ACUSON Aspen Diagnostic Ultrasound System

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  Class 2 Device Recall ACUSON Aspen Diagnostic Ultrasound System see related information
Date Initiated by Firm September 18, 2007
Date Posted February 15, 2008
Recall Status1 Terminated 3 on April 21, 2011
Recall Number Z-1107-2004
Recall Event ID 45411
510(K)Number K991805  
Product Classification Autoperfusion Software - Product Code IYN
Product Siemans- ACUSON Aspen Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system, Model Number: 8247887, Siemans, Mountain View, CA 94039
Code Information Serial Numbers: 32118 30032 33270 31789 30264 32770 33492 34115 22353203 40039-1 33468 33732 33808 33867 33906 33972 34080 34085 34104 34161 34168 34174 40009 40024 40046 40062 40093 40094 40101 40102 40132 40148 40163 40178 40187 40189 40197 40257 32603 33548 32611 30509 30991 31397 31770 31824 32018 32090 32551 32738 32927 31214 31518 30803 30828 31805 31875 33209 32053 32319 32497 32531 32830 33505 33421 32140 33515 33347 31997 30640 32141 32208 32209 32251 32450 32582 32625 32646 32796 32819 32886 32965 33020 33197 33206 33239 33269 33338 33454 33470 33494 32321 32117 32784 32831 32926 32581 31218 32992 33514 31117 33358 32674 31975 32539 32686 33712 31995 32718 31270 31804 33650 33433 32700 30167 33227 33757 33910 33796 33390 33098 33781 33995 33882 33516 33974 33709 33973 33992 31124 31619 33193 30033 31520 31876 30555 31335 30176 30472 33742 32741 32884 32887 30382 31599 32701 33432 32934 32761 32932 32540 32762 32827 32736 33041 32554 32583 33024 32978 32365 32496 32338 32449 32473 32917 32918 32514 32510 32222 32856 33059 32891 32877 33044 33049 33276 30412 30575 33300 31471 30993 31131 31363 33416 33261 33244 33230 33131 31810 31856 32042 33431 33195 33089 33162 33285 33060 33196 33101 33544 33070 31746 33283 33229 32143 33452 33517 33105 31367 33310 33724 33403 30834 33559 33587 33624 33652 30715 30315 33797 33774 33399 32772 32168 33032 31055 30695 33561 33672 32955 31976 31241 Material Number 8247888-- with Serial Numbers: 31116 32673 32783 33143 31359 31775 32848 32968 Material Number 8253683: with Serial Numbers: 40290 40311 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc.
1230 Shorebire Way
P.O. Box 7393
Mountain View CA 94043
For Additional Information Contact
650-969-9112
Manufacturer Reason
for Recall		 Software error: Error affects all Aspen customer systems using the PAL video standard configuration and have a Perspective PC installed. This can lead to a measurement error under this specific condition: On secondary capture images/clips stored from within any Perspective advanced display option (specifically: 3D Surface Rendering, 3D MultiPlanar Reconstruction, Color Doppler 3D MultiPlanar Reco
FDA Determined
Cause 2		 Software design
Action Siemens issued an Urgent Medical Device Notification to consignees 9/18/07, under Siemens update program US014/07/S. (Distribution on this product had ceased on 6/29/2005.) The firm has instructed the user to not take measurements or use measurements on these secondary captures under the conditions described in the notice, to place a copy of the instructions for use in the file, and to notify all users of the issue with the software. The Siemens Service organization has coordinated the implementation of the field correction with the distributors for all countries. Non-responding consignees will be visited or called by telephone for follow up.
Quantity in Commerce 280 units
Distribution Worldwide Distribution --- including USA and countries of Argentina, Australia, Austria, Belgium, Brazil, China, Czech Republic, Denmark, Egypt, France, Germany, Great Britain (UK), Greece, Hong Kong, India, Italy, Jordan, Malaysia, Norway, Poland, Portugal, Romania, Russian Federation, Sweden, Switzerland, Thailand, and Turkey.
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 = IYN and Original Applicant = ACUSON CORP.
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