Class 2 Device Recall ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35);

• Date Initiated by Firm: April 23, 2014
• Date Posted: May 28, 2014
• Recall Status: Terminated on November 12, 2015
• Recall Number: Z-1667-2014
• Recall Event ID: 68195
• 510(K)Number: K123622
• Product Classification: System, imaging, pulsed doppler, ultrasonic - Product Code IYN
• Product: ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system.
• Code Information: Model number 10433816; Serial numbers: US: 400290 400425 400439 400441 400443 400447 401176 401591 400763 400787 400789 400790 400791 400792 400794 400797 400063 400860 400868 400872 400873 400877 401041 401187 401441 401540 401590 401602 401662 401696 401638 401641 400174 400882 401612 401501 401507 401561 401378 400297 401423 401429 401550 401491 401494 401562 401572 401584 401621 400803 400821 400570 401010 401020 401235 401252 401564 401611 400998 400999 401601 401648 400979 401625 401631 400234 400312 400972 401433 400336 401645 400108 400177 400203 400313 400650 400663 400664 400176 400712 400716 401565 400128 400142 400782 400887 400889 401043 401554 400067 401257 401320 401559 401576 401633 401583 400875 400912 400925 400474 400902 401387 401476 401477 401547 401496 401567 401569 401570 401597 401607 401608 401618 401669 400630 401558 401587 401644 400227 400473 400577 400649 401294 401600 401596 ROW: 400652 400733 400737 400746 401437 401443 401478 401495 401188 401191 401650 400546 400945 401506 401371 401325 401393 401403 401543 401571 401580 401581 401613 401620 401623 400302 400348 400347 400553 400558 400726 400995 400996 401120 401123 401209 401260 401288 401338 401344 401442 401452 401551 401555 401556 401522 401560 401577 401579 401588 401589 401603 401604 401606 401643 401699 401630 401676 400125 400200 401434 401658 401661 401626 401435 401498 401217 401389 401431 401563 401585 401605 401687 400155 400180 400307 400704 401428 401451 401541 401521 401582 401594 401595 401624 401632 401637 401640 401666 401688 401689 401695 401004 401508 401546 401519 401627 400247 400263 400511 401045 400497 401664 400284 400252 401566 401502 400655 400214 401394 401367 401617 401634 401651 401652 401657 401659 401663 401665 401681 401685 401686 401694 401698 400253 400836 400840 401118 400218 400990 401127 40118. 0
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc.; 685 E Middlefield Rd; Mountain View CA 94043-4045
• For Additional Information Contact: Sheila Pickering; 650-694-5398
• Manufacturer Reason for Recall: Software issues with ACUSON SC2000 ultrasound with software version 3/5 (VA35) - may incorrectly display the color flow data in the wrong position and when Doppler Frequency is adjusted, the system does not restart the pulsed wave Doppler or continuous wave Doppler waveform.
• FDA Determined Cause: Software design
• Action: Siemens sent an Customer Safety Advisory Notification letter on April 23, 2014, to all affected customers. Distributors in foreign countries will implement delivery of notification to their customers. " Use the factory default presets with software version 3.5 instead of user-defined presets restored from software version 2.0 or 3.0. Review all patient studies on exams performed after software revision 3.5 was installed on your system. If you are unsure when this software was installed on your system, please contact your local Customer Service representative. " After adjusting the Doppler frequency, freeze and unfreeze the system. This action refreshes the display of the Doppler spectrum resulting in accurate measurements. Additional measurements performed after system freeze results in correct measurement values. Your local Customer Service Engineer will contact you to schedule an appointment to replace your existing version of software, free of charge. If you have any questions, please contact your local service support person for information regarding timelines and status. Until the new software has been installed on your system, please share this information with all personnel within your organization who need to be aware of this issue. As always, patient safety issues are a high priority, and we alert customers of product concerns which may occur under various conditions. To date, no patient injury has been reported as a result of these issues. We sincerely regret any inconvenience this condition may cause in your daily operations. For further questions call (650) 694-5398.
• Quantity in Commerce: 257 units
• Distribution: Worldwide Distribution - USA including the states of AL, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, KS, LS, MD, MI, MN, MO, NH, NY, NC, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA and WI., and the countries of Australia, Austria, Dominican Rep, France, Germany, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Mexico, New Zealand, Norway, Philippines, Poland, Portugal, Republic Korea, Romania, Russian Fed, Saudi Arabia, Sweden, Switzerland, Turkey, U.A.E. and United Kingdom.
• 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.