Class 2 Device Recall ACUSON Sequoia ultrasound systems

• Date Initiated by Firm: February 04, 2021
• Create Date: April 01, 2021
• Recall Status: Open, Classified
• Recall Number: Z-1330-2021
• Recall Event ID: 87362
• 510(K)Number: K193257
• Product Classification: System, imaging, pulsed doppler, ultrasonic - Product Code IYN
• Product: Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model; ; User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
• Code Information: Model: 11148775 Equipment Serial Numbers (U.S.) 800015 800101 800103 800104 800105 800106 800107 800108 800109 800111 800112 800113 800116 800118 800119 800121 800134 800138 800139 800141 800142 800143 800149 800150 800151 800152 800153 800155 800157 800158 800161 800165 800168 800172 800174 800175 800176 800177 800178 800182 800183 800184 800185 800186 800189 800190 800191 800192 800193 800194 800195 800196 800198 800199 800201 800203 800204 800205 800208 800209 800210 800211 800215 800217 800220 800221 800223 800225 800226 800227 800228 800229 800232 800233 800234 800235 800237 800239 800241 800242 800243 800244 800247 800249 800251 800254 800256 800257 800258 800259 800260 800263 800265 800267 800268 800270 800273 800274 800278 800280 800281 800285 800286 800291 800292 800293 800295 800300 800301 800302 800303 800304 800305 800308 800313 800314 800317 800319 800320 800321 800324 800328 800333 800335 800336 800339 800341 800342 800348 800349 800355 800360 800361 800363 800366 800369 800370 800375 800376 800383 800390 800393 800397 800405 800408 800411 800418 800424 800427 800428 800429 800433 800435 800436 800440 800451 800462 800463 800464 800466 800467 800469 800473 800474 800475 800480 800481 800486 800489 800490 800495 800498 800505 800506 800509 800511 800515 800516 800518 800521 800523 800525 800528 800532 800535 800540 800546 800549 800550 800552 800555 800556 800559 800560 800564 800566 800567 800579 800581 800583 800590 800592 800594 800597 800598 800607 800609 800611 800618 800623 800627 800628 800630 800631 800634 800638 800639 800640 800645 800648 800650 800651 800652 800653 800657 800661 800662 800667 800668 800671 800672 800673 800674 800675 800677 800680 800683 800686 800688 800693 800694 800696 800701 800703 800707 800708 800735 800738 800739 800741 800742 800743 800745 800747 800749 800752 800754 800756 800758 800760 800761 800762 800763 800771 800775 800786 800787 800788 800789 800791 800800 800805 800806 800807 800809 800813 800821 800834 800835 800854 800859 800861 800862 800863 800865 800866 800868 800869 800870 800871 800873 800874 800876 800878 800879 800880 800881 800882 800883 800884 800885 800887 800889 800890 800896 800901 800903 800904 800906 800907 800908 800912 800913 800914 800915 800917 800918 800920 800931 800933 800936 800940 800944 800945 800947 800952 800955 800959 800961 800963 800964 800979 800980 800993 800994 800998 801002 801003 801004 801005 801006 801007 801008 801009 801010 801011 801013 801014 801015 801016 801017 801018 801019 801021 801022 801023 801025 801026 801033 801034 801047 801080 801084 801087 801088 801089 801116 801117 801121 801123 801124 801125 801126 801127 801128 801129 801130 801131 801133 801134 801135 801136 801137 801138 801139 801140 801141 801144 801145 801147 801150 801152 801153 801156 801165 801166 801174 801177 801178 801191 801192 801193 801194 801196 801200 801202 801209 801211 801213 801223 801225 801230 801232 801234 801244 801245 801247 801248 801249 801259 801261 801271 801278 801279 801286 801300 801302 801306 801310 801311 801313 801314 801315 801316 801321 801324 801325 801326 801328 801330 801334 801336 801339 801345 801346 801347 801348 801352 801353 801356 801357 801358 801360 801363 801365 801366 801371 801372 801378 801381 801386 801390 801396 801400 801402 801405 801406 801408 801413 801414 801421 801423 801424 801426 801427 801430 801432 801435 801436 801437 801439 801441 801442 801443 801444 801447 801449 801450 801451 801452 801454 801458 801462 801463 801464 801465 801470 801471 801473 801474 801475 801476 801481 801483 801484 801488 801491 801492 801494 801495 801497 801499 801501 801502 801503 801506 801509 801510 801514 801515 801516 801517 801519 801521 801524 801527 801528 801529 801530 801531 801532 801534 801535 801536 801537 801538 801539 801540 801541 801542 801543 801544 801545 801548 801549 801550 801552 801553 801554 801555 801556 801558 801559 801564 801565 801567 801572 801574 801576 801579 801594 801596 801598 801605 801609 801610 801611 801629 801631 801632 801636 801639 801641 801642 801643 801645 801647 801648 801649 801650 801655 801660 801663 801675 801678 801680 801685 801708 801714 801759 801760 801768 801771 801812 801903 801911 802004 802008 802017 802019 802022 802028 802029 802032 802033 802093 802109 802125 802128 802146 802164 802217 802245 802263 Equipment Serial Numbers (O.U.S.): 800344 800438 800932 801787 801851 801020 801927 801982 801988 802069 802073 802078 802079 802081 802083 802084 802086 802123 802131 802135 802140 802147 802180 802181 802183 802185 802186 802187 802188 802189 800114 800115 800117 800120 800122 800123 800126 800127 800129 800130 800133 800135 800136 800140 800147 800148 800159 800162 800163 800166 800167 800169 800170 800171 800181 800187 800197 800206 800207 800212 800214 800218 800219 800224 800230 800231 800236 800245 800246 800248 800250 800252 800264 800266 800271 800277 800279 800282 800284 800288 800298 800309 800311 800312 800315 800323 800329 800334 800337 800338 800340 800343 800345 800346 800350 800356 800358 800362 800364 800365 800367 800368 800377 800379 800380 800382 800388 800391 800392 800398 800399 800400 800401 800404 800406 800409 800410 800412 800413 800416 800417 800421 800423 800425 800426 800430 800431 800432 800434 800439 800447 800449 800450 800456 800457 800458 800472 800477 800478 800483 800484 800488 800492 800494 800500 800503 800508 800517 800520 800527 800529 800530 800531 800536 800542 800543 800544 800548 800557 800561 800563 800572 800575 800584 800585 800586 800591 800599 800600 800601 800602 800605 800606 800610 800612 800613 800614 800617 800620 800621 800622 800624 800625 800632 800636 800637 800642 800644 800646 800647 800649 800654 800658 800659 800663 800664 800669 800678 800682 800695 800698 800699 800700 800702 800705 800706 800730 800731 800734 800737 800750 800753 800764 800766 800767 800769 800776 800779 800780 800783 800785 800793 800794 800802 800803 800804 800817 800818 800820 800822 800825 800828 800830 800832 800836 800838 800840 800841 800845 800846 800847 800850 800852 800855 800856 800857 800860 800875 800892 800894 800897 800899 800900 800909 800911 800916 800919 800921 800922 800923 800924 800926 800927 800928 800930 800934 800937 800941 800942 800946 800948 800949 800950 800965 800968 800974 800976 800977 800978 800981 800982 800984 800988 800992 800996 800997 800999 801012 801024 801032 801036 801037 801041 801044 801061 801065 801070 801074 801077 801081 801082 801083 801086 801149 801151 801162 801170 801175 801205 801212 801218 801238 801243 801252 801253 801254 801255 801257 801269 801303 801305 801308 801309 801317 801318 801331 801332 801337 801342 801343 801344 801354 801355 801359 801364 801367 801368 801370 801373 801375 801376 801380 801383 801384 801391 801392 801393 801399 801407 801410 801415 801417 801420 801422 801428 801446 801453 801456 801466 801467 801469 801472 801480 801487 801493 801496 801498 801505 801507 801508 801511 801513 801520 801522 801526 801533 801546 801547 801551 801560 801561 801562 801563 801569 801575 801577 801578 801584 801586 801589 801591 801592 801595 801597 801602 801603 801606 801607 801624 801626 801638 801644 801646 801651 801652 801653 801654 801656 801661 801664 801669 801670 801673 801736 801761 801762 801763 801764 801765 801766 801769 801772 801773 801774 801777 801778 801779 801780 801781 801782 801783 801786 801788 801791 801792 801793 801794 801795 801796 801797 801798 801799 801800 801801 801802 801803 801805 801806 801809 801810 801811 801813 801815 801816 801817 801818 801819 801820 801821 801823 801824 801828 801829 801830 801831 801835 801836 801837 801838 801839 801842 801844 801846 801847 801848 801849 801853 801859 801862 801875 801876 801889 801892 801898 801901 801902 801907 801908 801915 801933 801934 801935 801936 801937 801965 801971 801972 801973 801976 801978 801983 801984 801991 801992 801994 801995 802003 802007 802009 802010 802012 802015 802018 802020 802021 802023 802024 802070 802072 802080 802087 802089 802096 802100 802103 802104 802107 802108 802111 802112 802113 802114 802115 802117 802118 802119 802122 802126 802127 802129 802130 802133 802134 802136 802137 802143 802193 802213 802219 802220 802229 802230 802241 802251 802252 802258 802269 802273
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc.; 22010 SE 51st St; Issaquah WA 98029-7298
• For Additional Information Contact: Mr. Khalil Thomas; 425-392-9180
• Manufacturer Reason for Recall: The ultrasound system averages the Mean Sac Diameter (MSD) and Gestational Sac Diameter (GSD) into the Estimated Date of Delivery (EDD) calculation. This may result in an incorrect EDD, which may influence patient management decisions regarding induction of labor and elective caesarean delivery, which may result in premature births.
• FDA Determined Cause: Software Design Change
• Action: On 02/04/2021, the firm sent an "CUSTOMER SAFETY ADVISORY NOTIFICATION" email to customer informing them that the ultrasound system averages the Mean Sac Diameter (MSD) and Gestational Sac Diameter (GSD) into the Estimated Date of Delivery (EDD) calculation. This may result in an incorrect EDD. An incorrect EDD may influence patient management decisions regarding induction of labor and elective caesarean delivery, which may result in premature births. -Customers are instructed to avoid this issue, delete any MSD or GSD values from the patient report if other biometric parameters are measured. -Recalling Firm recommends a review of any early obstetric or gynecology ultrasound results for current pregnancies which produced a gestational age using MSD or GSD as an input. -The issue will be corrected by the Recalling Firm with an updated to the software and a Customer Service Engineer will contact customers to schedule a facility visit to update the software or updates will be issued via the Remote Update Handling process. -Customers are instructed to inform their personnel accordingly. Additional questions or assistance - contact Quality & Regulatory at 732-331-6672 or email khalil.thomas@siemens-healthineers.com.
• Quantity in Commerce: 1,172 systems
• Distribution: U.S.: AK, AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY O.U.S.: U.A.E., Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Israel, Italy, Japan, Kazakhstan, Kuwait, Mexico, Morocco, Netherlands, New Zealand, Oman, Philippines, Poland, Portugal, Qatar, Republic Korea, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, and Vietnam
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = IYN and Original Applicant = Siemens Medical Solutions USA, Inc