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U.S. Department of Health and Human Services

Class 2 Device Recall Acuson S1000

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  Class 2 Device Recall Acuson S1000 see related information
Date Initiated by Firm April 25, 2012
Date Posted May 16, 2012
Recall Status1 Terminated 3 on October 19, 2012
Recall Number Z-1616-2012
Recall Event ID 61803
510(K)Number K111674  
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
Product ACUSON S1000 ultrasound systems running software version 1.0, Siemens Medical Solutions, USA, Inc. Mountain View, CA. The product is indicated for use as an ultrasound imaging system.
Code Information Serial numbers: 205730 205732 205523 205557 205721 205704 205747 205709 205685 205796 205751 205797 205771 205786 205795 205775 205785 205773 205783 205782 205791 205793 205789 205804 205873 205848 205821 205811 205840 205708 205909 206029 206072 205814 205977 205935 205971 206089 206120 205988 206112 206038 206087 205956 205937. 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc.
685 E Middlefield Rd
Mountain View CA 94043-4045
For Additional Information Contact Karen Smith
650-969-9112
Manufacturer Reason
for Recall		 When using the Advanced SieClear spatial compounding feature a synchronization error may occur which can cause a mismatch between the image and the depth scale.
FDA Determined
Cause 2		 Software design
Action A field corrective action was initiated on 04/25/2012 under Siemens update program US019/12/S in which a "Customer Safety Advisory Notice" was sent to all customers notifying them of the problem and the recommended actions to avoid potential risk. A follow-up field corrective action will be initiated in which the affected software will be updated in the field.
Quantity in Commerce 45
Distribution Worldwide Distribution -- USA, including the states of TX, NJ, GA and the countries of Germany, United Kingdom, Republic of Korea, Australia, Japan, Poland, Israel, Singapore, France and Saudi Arabia.
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 = SIEMENS MEDICAL SOLUTIONS USA, INC.
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