{ "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": "2026-04-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "country": "United States", "city": "Mountain View", "address_1": "685 E Middlefield Rd", "reason_for_recall": "The application may underestimate the EROA (Effective Regurgitant Orifice Area) in comparison to the same patient results obtained with the 4Z1c volume transthoracic echocardiography transducer.", "address_2": "", "product_quantity": "564 systems", "code_info": "Software versions VB10A, VB10B, VB10D, VB10E that have PRIME license 11146943 and eSie PISA license 10439823. Serial numbers involved are: 400154 400173 400201 400252 400278 400294 400355 400423 400497 400518 400606 400614 400655 400761 400836 400840 400888 400899 400909 401173 401186 401195 401207 401230 401246 401254 401259 401289 401361 401367 401377 401423 401429 401443 401444 401451 401452 401454 401455 401491 401494 401501 401546 401561 401565 401567 401569 401572 401577 401580 401589 401603 401604 401606 401607 401612 401627 401643 401649 401654 401658 401661 401697 401699 401704 401711 401724 401731 401751 401757 401761 401762 401770 401775 401776 401784 401794 401807 401812 401815 401819 401823 401836 401844 401869 401876 401886 401887 401908 401910 401911 401921 401924 401962 401970 401993 402015 402018 402056 402061 402066 402067 402069 402071 402073 402075 402079 402088 402090 402091 402092 402116 402119 402122 402136 402138 402139 402140 402141 402144 402145 402161 402168 402172 402173 402176 402177 402188 402189 402194 402197 402200 402203 402210 402213 402214 402215 402216 402218 402219 402225 402226 402236 402242 402259 402267 402268 402270 402271 402272 402273 402274 402275 402277 402278 402290 402295 402296 402299 402300 402301 402302 402303 402304 402307 402309 402313 402316 402318 402326 402327 402328 402332 402333 402337 402339 402340 402343 402344 402347 402348 402349 402350 402352 402354 402355 402369 402370 402371 402374 402377 402381 402383 402384 402385 402389 402392 402393 402400 402405 402410 402411 402412 402414 402416 402421 402423 402424 402428 402429 402432 402433 402435 402437 402438 402440 402450 402452 402456 402459 402465 402467 402469 402472 402481 402485 402492 402503 402504 402505 402508 402516 402520 402526 402529 402535 402539 402544 402545 402552 402553 402555 402558 402562 402565 402567 402568 402569 402575 402577 402579 402580 402582 402583 402584 402585 402589 402590 402592 402595 402599 402602 402606 402617 402618 402619 402627 402628 402629 402641 402643 402646 402647 402648 402651 402653 402654 402659 402660 402669 402670 402671 402675 402681 402682 402685 402697 402698 402700 402701 402702 402705 402706 402708 402713 402714 402715 402718 402719 402720 402722 402723 402725 402732 402737 402741 402742 402743 402745 402749 402753 402755 402761 402766 402769 402771 402773 402780 402781 402782 402783 402784 402787 402796 402798 402799 402804 402807 402808 402811 402825 402826 402836 402840 402842 402845 402847 402848 402850 402851 402852 402857 402861 402869 402876 402881 402883 402885 402886 402887 402889 402896 402897 402898 402902 402905 402906 402907 402909 402911 402912 402915 402920 402921 402923 402925 402926 402927 402930 402934 402935 402941 402942 402944 402948 402950 402956 402957 402959 402962 402971 402974 402977 402979 402992 402993 402994 402999 403000 403001 403002 403003 403005 403012 403014 403015 403016 403017 403021 403023 403027 403028 403030 403034 403036 403038 403041 403043 403047 403065 403068 403070 403074 403075 403076 403077 403084 403087 403091 403093 403095 403096 403098 403105 403117 403120 403123 403125 403128 403130 403131 403133 403146 403147 403150 403151 403156 403157 403159 403163 403167 403170 403171 403175 403177 403184 403189 403192 403201 403203 403207 403211 403212 403217 403219 403220 403221 403223 403224 403255 403257 403264 403274 403275 403277 403281 403285 403286 403294 403300 403301 403303 403306 403321 403323 403328 403333 403336 403341 403342 403343 403344 403345 403347 403349 403350 403353 403356 403359 403360 403364 403365 403366 403370 403373 403374 403377 403382 403389 403392 403393 403395 403398 403400 403402 403404 403407 403411 403416 403422 403423 403426 403427 403432 403434 403435 403437 403438 403447 403452 403454 403455 403457 403462 403469 403470 403471 403481 403485 403495 403496 403517 403518 403519 403520 403526 403527 403531 403536 403549 403743 403744 403745 403748 403749 403819 403829 403831 403833 403834 403835 403838 403844 403853 403854 403856 403859 403864 403865 403866 403872 403879 403880 and 403882", "center_classification_date": "20180315", "distribution_pattern": "Worldwide Distribution - U.S. nationwide and the countries of Algeria, Argentina, Australia, Austria, Azerbaijan, Brazil, Brunei, Canada, Chile, China, Columbia, Ecuador, Egypt, El Salvador, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Malaysia, Malta, Mexico, Netherlands, Norway, Pakistan, Philippines, Poland, Portugal, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, U.A.E, Ukraine, United Kingdom, United States, Uzbekistan, and Vietnam.", "state": "CA", "product_description": "ACUSON SC2000 Ultrasound System 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": "20180321", "classification": "Class II", "openfda": {}, "recalling_firm": "Siemens Medical Solutions USA, Inc.", "recall_number": "Z-1065-2018", "initial_firm_notification": "Letter", "product_type": "Devices", "event_id": "79328", "termination_date": "20200702", "more_code_info": "", "recall_initiation_date": "20180126", "postal_code": "94043-4045", "voluntary_mandated": "Voluntary: Firm initiated", "status": "Terminated" } ] }