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U.S. Department of Health and Human Services

Class 2 Device Recall ACUSON SC2000 Ultrasound imaging system

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  Class 2 Device Recall ACUSON SC2000 Ultrasound imaging system see related information
Date Initiated by Firm April 08, 2016
Create Date May 02, 2016
Recall Status1 Terminated 3 on January 18, 2017
Recall Number Z-1592-2016
Recall Event ID 73854
510(K)Number K123622  
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
Product ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M.
Model number: 10433816.
Code Information Model number 10433816; Serial numbers: 402192 400889 402498 402549 400887 402791 401002 402278 402289 402301 401182 402879 400462 400649 402206 402211 402496 402499 401631 402475 400456 402392 402828 402814 400852 401010 402509 400221 400312 402413 402568 402460 402652 402673 402664 400234 402789 401751 401040 400519 402800 400775 400671 401445 402546 402542 402771 402764 401117 401252 402454 402476 402500 402513 402511 401305 401130. 
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc.
685 E Middlefield Rd
Mountain View CA 94043-4045
For Additional Information Contact Scott Christiansen
650-964-5398
Manufacturer Reason
for Recall
While imaging with a transesophageal (TEE) transducer (Z6Ms, V5Ms, or V7M), user may lose the ability to control the color region of interest, the pulsed wave or continuous wave Doppler gate or cursor, the M-mode cursor, the 2D field of view, or the RES region of interest with the trackball.
FDA Determined
Cause 2
Software design
Action Under Siemens update program US013/16/S a Customer Advisory Notification will be mailed to all affected customers by Certified mail with return receipt beginning March 30, 2016. Letters provide customers information on how to avoid the issue until the software patch is installed.
Quantity in Commerce 87
Distribution Worldwide distribution. US nationwide, Austria, Canada, China, Germany, India, Italy, Spain, Sweden, and Switzerland.
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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