{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "country": "United States", "city": "Mountain View", "address_1": "685 E Middlefield Rd", "reason_for_recall": "The ACUSON SC2000 ultrasound system considers uppercase/lowercase differences in the same patient name as unique patient instances when registered on the same ultrasound system. If these differences are not corrected at the time of registration, the system does not capture images or clips.", "address_2": "", "product_quantity": "2039 devices", "code_info": "Model 10433816: Serial numbers: 400217 400290 400425 400439 400441 400443 400447 401496 401719 402310 402495 400308 400641 400770 401110 401114 401135 401136 401138 401169 401174 401176 401370 401406 401366 401460 401591 401750 401753 401793 401803 402090 402139 402177 402197 402255 402323 402327 402339 402351 402387 402492 402508 400261 400350 400763 400787 400789 400790 400791 400792 400794 400797 400881 400886 400888 400890 400892 400898 400923 400951 400978 401023 401025 401957 402451 400090 400066 400063 400868 400873 401041 401540 402109 400139 400141 400171 400235 400287 400291 400292 400293 400351 400337 400338 400458 400459 400475 400526 400527 400529 400583 400589 400593 400620 400693 400743 400843 400872 400877 400878 400891 400895 400921 400958 400959 400960 400970 400989 401001 401012 401029 401031 401044 401065 401075 401081 401083 401130 401132 401139 401187 401237 401243 401271 401286 401291 401305 401426 401441 401445 401590 401662 401725 401728 401744 401746 401758 401810 401832 401841 401863 401910 401969 402011 402027 402050 402051 402131 402190 402226 402242 402243 402244 402257 402260 402275 402296 402396 402398 402444 400720 400100 400492 400914 401108 401109 401255 401638 401641 401845 402279 400065 400715 400174 400440 400448 400538 400541 400572 400615 400622 400623 400626 400799 400830 400882 400931 401049 401115 401375 401285 401343 401397 401402 401409 401424 401425 401430 401570 401730 401734 401991 402026 401890 401898 401899 401906 400029 400195 400070 400223 400224 400233 400309 400454 400456 400530 400552 400617 400814 400818 400835 401204 401281 401476 401547 401565 401567 401568 401602 401612 401900 401950 401959 401961 402280 402322 402341 402449 401173 401289 400472 401501 401507 401552 401600 401705 401797 401825 401837 402236 402386 400822 400676 400678 400665 400683 400145 400179 400310 400311 400968 401378 401446 401497 400175 400226 400236 400245 400244 400264 400267 400269 400283 400288 400297 400536 400629 400640 400679 400680 400717 400757 400759 400768 400773 400775 400788 400795 400800 400832 400848 400874 400883 400884 400885 400905 400967 400974 401028 401111 401258 401265 401266 401278 401379 401384 401386 401391 401348 401423 401429 401550 401491 401494 401572 401584 401592 401610 401621 401636 401639 401674 401678 401732 401737 401747 401862 401864 401867 401872 401918 401987 402025 402028 402081 402118 402200 402215 402216 402320 402407 402448 402481 400220 400221 400435 400437 400451 400767 400803 400821 400862 400986 401177 401453 401462 401574 401575 401765 402406 402489 401040 400570 401007 401010 401020 401235 401252 401520 401564 401611 401804 401846 402030 402336 402454 402476 402500 402513 402511 401691 401771 402143 402271 402273 402290 402306 402325 400442 400486 400487 400489 400564 400998 400999 401979 402029 400449 401562 401597 401648 402094 400048 400118 400132 400143 400295 400093 400431 401216 400299 400023 400120 400126 400265 400326 400069 400480 400485 400550 400689 400700 400691 400742 400786 400893 400913 400979 401112 401373 401315 401351 401461 401625 401631 402023 402031 402048 402258 402313 402319 402332 402357 402391 402431 402484 400088 400123 400137 400152 400197 400234 400312 400436 400477 400669 400817 400929 400972 401054 401055 401067 401071 401503 401836 402010 402018 402022 402056 402125 402127 402145 402168 402214 402220 402222 402228 402230 402253 402254 402318 402333 402337 402354 402377 402421 402412 401708 400483 400484 400513 400535 400847 401003 401013 401014 401134 401234 401256 401369 401392 401410 401539 402316 402317 402330 402334 402345 402397 402399 402375 400024 400022 401250 401322 401323 401327 401433 401124 401458 401533 401553 401656 401660 402223 400336 400196 400464 400671 400988 401194 401247 401500 401405 401346 401710 401713 401760 401769 401787 401859 401881 401883 401902 401915 401916 401917 402077 402102 402229 402256 402268 402287 402315 401645 401774 402064 402285 402453 402447 402417 400108 400135 400138 400156 400177 400203 400222 400228 400246 400313 400318 400317 400322 400324 400446 400452 400455 400457 400465 400471 400496 400621 400650 400663 400664 400668 400667 400675 400698 400899 400991 401015 401030 401078 401090 401175 401246 401241 401248 401249 401345 401404 401360 401475 401573 401599 401628 401751 401782 401821 401839 401849 401850 401847 401855 401856 401857 401860 401877 402086 402175 402248 402250 402282 402305 402379 402411 402400 400117 400131 400084 400176 400712 400716 400907 400953 400964 401008 401070 401244 401361 401629 401801 401827 401878 401880 402249 402262 401444 400128 400142 400163 400086 400672 400708 400736 400782 400810 400811 400887 400889 401043 401069 401155 401156 401181 401182 401193 401226 401245 401267 401268 401269 401279 401280 401287 401554 401586 401868 401885 401940 402014 402049 402057 402082 402087 402095 402192 402382 402392 402371 402374 402429 400067 400595 400613 400894 400940 400954 400955 400962 401802 402154 400662 400674 400687 400813 401116 401236 401257 401320 401559 401576 402041 402219 400122 400168 400194 400081 400204 400229 400230 400314 400316 400346 400438 400460 400461 400462 400463 400466 400467 400470 400479 400493 400501 400516 400519 400520 400545 400638 400666 400829 400851 400852 400855 400857 400956 400944 400994 400997 400965 401011 401022 401088 401080 401117 401141 401149 401158 401184 401300 401290 401308 401311 401314 401319 401326 401333 401335 401336 401383 401347 401365 401422 401438 401440 401557 401578 401616 401633 401653 401683 401693 401700 401729 401733 401799 401873 401882 401914 401927 402012 402020 402021 402054 402191 402264 402353 402369 402376 402436 400930 401190 400517 400740 401137 401363 401364 401583 400860 400875 400912 400925 400225 400404 400355 400474 400634 400900 400902 400154 400153 400258 400303 400304 400528 400548 400555 400992 401061 401282 401328 401385 401387 401407 401427 401450 401493 401569 401607 401608 401618 401669 401697 401706 401711 401724 401772 401776 401800 401826 401830 401840 401843 401848 401851 401879 401889 401892 401907 401911 401929 401943 401981 402068 402083 402089 402237 402238 402283 402286 402303 402307 402326 402423 402420 402457 402478 402501 400554 400694 400630 400102 400162 400861 400985 401089 401538 401558 401587 401644 402312 402338 402418 401680 400124 400227 400473 400577 400649 401505 401294 401727 401813 402078 402206 402211 402233 402252 402299 402439 402456 402496 402499 400050 401561 401655 402162 400130 400129 400481 400573 400610 400618 400776 400820 401198 401213 401307 401432 401474 401489 401596 401735 401741 401743 401795 401838 401908 401919 401922 402266 402278 402284 402289 402301 402413 402514 401063 401436.", "center_classification_date": "20150917", "distribution_pattern": "Worldwide distribution. US Nationwide and the countries of Albania, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia Herzeg., Brazil, Brunei, Bulgaria, Canada, Colombia, Croatia, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt, El Salvador, Finland, France, Georgia, Germany, Hungary,, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Lithuania, Malaysia, Maldives, Malta, Mauritius, Mexico, Netherlands, New Zealand, Nigeria, Norway, Oman, P.R. China, Pakistan, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Russian Fed., San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Suriname, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Turkmenistan, U.A.E., Ukraine, United Kingdom, Uzbekistan, Venezuela, and Vietnam.", "state": "CA", "product_description": "ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model 10433816; Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.", "report_date": "20150923", "classification": "Class II", "openfda": {}, "recalling_firm": "Siemens Medical Solutions USA, Inc.", "recall_number": "Z-2783-2015", "initial_firm_notification": "Letter", "product_type": "Devices", "event_id": "72094", "termination_date": "20171019", "more_code_info": "", "recall_initiation_date": "20150819", "postal_code": "94043-4045", "voluntary_mandated": "Voluntary: Firm initiated", "status": "Terminated" } ] }