Device Recall ACUSON SC2000 Ultrasound System

Model number 10433816. serial numbers 401100 to 401400.

Radiology Devices

2

No

Worldwide Distribution - USA and the countries of Australia, Austria, Belarus, Canada, Ecuador, Finland, France, Georgia, Germany, India, Iraq, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Nigeria, P.R. China, Philippines, Portugal, Republic Korea, Russian Fed., Saudi Arabia, Serbia, South Africa, Spain, Suriname, Sweden, Taiwan, Turkey, U.A.E. and United Kingdom.

ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. || 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.

Serial Numbers: 400935 400140 400532 400580 400582 400592 400597 400635 400643 400652 400685 400686 400733 400737 400746 400752 400753 400771 400777 400784 400833 400919 400499 400896 400809 400296 400111 400319 400793 400699 400849 400816 400213 400212 400215 400251 400254 400407 400560 400670 400713 400722 400729 400730 400731 400734 400764 400766 400815 400920 400945 400149 400289 400341 400444 400510 400547 400562 400575 400732 400779 400904 400936 400939 400980 400987 401009 400321 400549 400922 400125 400199 400200 400043 400755 400808 400926 400426 400756 400806 400950 400424 400566 400711 400727 400801 400834 400911 400927 400933 400827 400127 400637 400642 400205 400880 400690 400745 400778 400802 400240 400591 400432 400780 400785 400819 400824 400825 400826 400838 400842 400844 400845 400863 400869 400871 400910 400937 400938 400724 400846 400973 400219 400300 400158 400159 400172 400181 400182 400187 400191 400192 400211 400249 400250 400279 400298 400301 400339 400512 400544 400579 400588 400590 400688 400738 400739 400741 400798 400812 400761 400837 400841 400850 400655 400839 400870 400879 400917 400578 400278 400423 400563 400606 400769 400901 400116 400165 400178 400214 400262 400266 400274 400275 400271 400414 400420 400430 400616 400760 400823 400876 400915 400928 400934 400253 400403 400412 400498 400581 400728 400765 400189 400897 400924 400908 400796 400836 400840 400946 400948 400957 400963 400218 400277 400856

Radiology Devices

2

No

Worldwide Distribution -- US and Albania, Australia, Austria, Bangladesh, Bulgaria, Canada, Colombia, Denmark, Ecuador, Egypt, France, Germany, Hungary, Iceland, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mauritius, Mexico, Netherlands, P.R. China, Philippines, Portugal, Rep. of Yemen, Republic Korea, Russian Fed., San Marino, Saudi Arabia, Singapore, Spain, Suriname, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., United Kingdom, and Venezuela.

ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816. || 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.

Model number 10433816 between software version VA16A and VA30A: US Serial numbers: 400930 401216 401375 401343 401049 400538 401115 400572 400464 401346 400196 401030 401246 400222 400455 400457 401090 401078 400318 401345 400668 400667 401158 400545 401022 401184 401308 401141 401311 400462 400467 400460 400461 401383 400466 401149 401300 400479 400493 400519 400861 400117 401070 400907 400740 400552 400454 401204 400530 400814 400818 400835 400900 400810 400811 401155 401156 400736 401279 401280 400220 400221 400742 400913 401351 400069 400326 400123 400137 400197 400234 400152 401322 401323 401327 400967 400974 400884 400795 401265 401266 401258 400848 400874 400883 400175 401348 400759 400226 400885 400757 400472 400536 401278 400236 400629 400640 401384 400800 400768 400775 400679 400680 400269 400483 400484 401234 401256 401003 401013 401014 400886 400890 400898 400794 400797 400978 401023 401025 400940 400954 400955 400992 400153 400554 401061 401328 400914 400715 400065 401169 401174 400770 401533 400958 401271 401286 401237 400475 401187 400970 400693 400589 401305 401075 401031 400291 400676 400678 400665 400683 401257. ROW serial numbers: 400935 400604 400682 400597 400833 400140 400753 401016 400166 400582 400983 401036 400784 400919 401376 401159 400186 400499 400896 400809 401160 400774 400282 400758 400723 401532 400402 400633 400296 400111 400319 400515 400942 400793 400343 400849 401400 400816 401143 400216 400212 400713 400215 400730 400734 401021 400920 401140 401239 401128 401052 400815 400766 401133 401018 400729 400731 400213 400903 401334 401048 401056 400722 401273 401225 401210 400904 401229 400980 400961 400941 400325 400562 400242 400444 400149 400547 400939 400510 401050 401142 400779 400341 400289 400987 401009 400321 400549 401077 400922 400702 400043 401329 401253 401295 400755 400808 400926 400150 401119 400806 400426 400428 400429 400756 401312 401192 401126 400711 401293 400566 400977 401079 400551 401219 400696 400834 400500 401276 401238 400207 401242 401317 401349 400933 401218 401199 400115 400418 400416 400422 400599 400600 401240 401215 400608 400601 401313 401068 400927 400424 400421 400185 400827 400127 400642 401396 400880 400205 401251 400690 400745 401074 401203 400802 400778 400614 400524 400523 400240 400591 401324 400469 401046 401535 401483 401834 400627 401340 401032 401264 400819 401716 401058 401062 400113 400241 400825 401357 401779 401672 401421 401717 401778 401167 401310 400328 400910 401222 401482 401202 401740 400869 401059 401413 401738 401419 401206 401416 401212 401828 401486 401170 400598 401057 400677 400826 401468 400332 400824 401352 400607 401702 401164 400842 401076 400419 400323 401703 401263 401201 400329 401354 401485 401341 401679 401531 401299 401221 400859 401162 401053 401097 400785 401298 401714 401715 401205 400644 401484 401742 400602 401670 400237 400432 401790 401829 401414 400413 400938 400625 401739 400335 400976 401168 400330 401418 401417 401682 401339 400525 400714 401095 401677 401166 400333 401792 401094 401172 401480 401701 400838 400971 401415 400434 400845 401479 401671 400906 401171 400863 401296 400706 400871 401789 401262 401534 401420 401675 400286 400780 401051 400256 400937 401353 400327 401831 401318 400724 400973 400490 400219 401039 400966 401017 400300 400201 401183 401195 401026 401145 401207 400739 400761 400187 400544 400741 400339 400632 401331 400494 400805 401129 400161 400537 400211 400159 400160 400181 401146 401153 400249 400248 400298 400301 400087 401200 400192 401220 400170 400184 400812 401085 401082 401087 401178 400718 400837 400841 400750 400751 400705 400561 400850 400542 400417 400574 400917 401151 400559 400571 401147 401211 401228 401230 401233 400255 401301 400839 400748 400870 400879 401231 401148 400585 401019 401024 401321 401277 400645 400606 400692 400521 400725 400769 400423 400563 400943 400701 401332 400928 400934 400823 400165 400765 400728 401042 400189 401154 400969 400897 400924 400908 400587 401086 400646 400796 401084 401306 400619 401000 400946 400948 400957 400963 401185 400603 401127 400476 401197 400856.

Radiology Devices

2

No

Worldwide Distribution - US Distribution and to the countries of : Albania, Angola, Armenia, Australia, Austria, Bangladesh, Belarus, Bolivia, Bosnia Herzog, Brazil, Brunei, Bulgaria, Canada, Colombia, Czech Republic, Ecuador, Egypt, Finland, France, Germany, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Kuwait, Lithuania, Malaysia, Maldives, Mauritius, Mexico, Netherlands, Nigeria, Oman, P.R. China, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Russian Fed, San Marino, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Suriname, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., United Kingdom and Venezuela

ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. || Model number 10433816: || 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.

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.

Radiology Devices

2

No

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.

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.

Software versions VB20A, VB20B, or VB20C that have a common physio module (CPM) (known by customers as the ECG (physio) hardware) installed at revision 4

Radiology Devices

2

No

Distribution was made to medical facilities in AZ, CA, CT, FL, IL, IN, KS, KY, MI, MN, MO, NJ, NY, NC, OH, PA, TX, VA, and WA. There was no military/government distribution. Foreign distribution was made to Argentina, Australia, Austria, Belgium, Bosnia Herzeg, Colombia, Croatia, Denmark, France, Germany, India, Ireland, Israel, Italy, Japan, Mexico, New Zealand, Philippines, Poland, Republic Korea, Romania, Singapore, Slovakia, Spain, Sweden, Taiwan, Thailand, Turkey, UAE, and Vietnam.

ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.