{ "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": [ { "status": "Terminated", "city": "Malvern", "state": "PA", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "75555", "recalling_firm": "Siemens Medical Solutions USA, Inc", "address_1": "40 Liberty Blvd", "address_2": "N/A", "postal_code": "19355-1418", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "US Nationwide Distribution", "recall_number": "Z-0604-2017", "product_description": "SOMATOM Definition AS, Computed tomography system Product Usage: SOMATOM Definition Flash systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.", "product_quantity": "762 systems distrtibuted in U.S.", "reason_for_recall": "A problem can occur with the small light marker windows, used for the positioning laser and are integrated in the front cover of the SOMATOM Definition AS and Definition Flash systems, by either becoming loose or potentially dropping out. There is a risk that a person could touch rotating or electrical parts of the gantry if they were to reach through the window opening.", "recall_initiation_date": "20161019", "center_classification_date": "20161116", "termination_date": "20170313", "report_date": "20161123", "code_info": "Serial Numbers: 73064 64789 64492 65127 64464 64471 65380 66632 65852 64668 64239 65364 64580 73476 73339 64278 64756 73059 64800 64412 65288 64645 64725 73421 64508 65339 65346 64714 65831 64123 64246 65690 65752 64658 73312 66858 65491 66611 64465 65076 64454 65762 64485 64446 64673 66319 64419 66518 65968 66506 66171 66243 73544 64368 64736 65620 64081 64117 64549 65175 65569 64112 66287 66292 64164 64180 66087 65322 65768 65425 65810 73343 73374 65326 64461 65764 66929 65615 66251 66327 66826 64497 66146 64067 64428 65355 66635 66225 65039 64111 65314 64371 66188 66355 66476 64138 73518 65209 66467 64860 66649 66182 73258 64342 73579 64372 66998 66759 64420 65264 66150 64235 65712 66461 66604 73120 66411 64179 65515 66498 73108 64178 66688 66164 64172 66433 66141 64074 66572 66944 64253 65015 66768 64482 64170 66405 64825 64328 65075 65671 64418 65437 66222 65263 66406 66574 65713 64270 66700 65926 73427 66475 65614 73187 65013 66791 64909 65014 65110 65856 64429 65087 65197 64764 64570 64467 64410 73533 64248 64604 66119 66193 64841 64707 64821 73423 73424 73493 73520 66233 65804 66085 73459 64290 64274 65306 66790 64337 65554 73303 65960 64734 65036 73240 73279 73278 64575 64289 64724 65311 65366 65407 64623 66451 64685 73224 66928 65403 64079 64823 64905 66690 64807 64770 66964 65568 66924 64709 64082 65233 66075 66626 66965 66151 66911 64863 65959 66557 65576 66148 66705 65418 66822 73352 64968 64481 65393 65755 66450 65799 65501 66234 65413 66556 73526 65186 65927 65466 65267 64296 64421 64423 66745 64259 65802 73487 73492 73494 73497 64430 73016 73310 65286 65302 66918 64801 64284 66527 64624 66458 64959 66850 73409 64627 64692 64397 64947 64228 66472 64463 65283 66667 64913 65736 64835 64834 65423 65313 66011 65081 65279 64635 66297 64078 66818 65818 64931 64244 65530 65412 65446 66683 66704 66999 66396 64068 64629 66201 65012 73130 66914 66802 66304 66423 66473 64291 73013 73300 73499 73535 73090 73377 64402 65480 65062 66237 66595 64953 64194 73031 64190 64455 64783 65265 66952 66154 65278 64260 66183 65974 66079 64536 73355 65793 65792 66252 64695 64693 65728 64282 73330 66789 65261 66074 65021 65044 65628 64729 64424 64694 66844 73366 66232 64605 65725 73036 64166 66615 66804 66032 66089 66128 66039 65925 65112 65940 64231 64960 66078 66642 64263 66173 66180 64773 65821 73285 64293 73281 65328 65304 66582 66846 64103 65223 64659 66810 66843 73248 64232 64299 66887 66638 64241 65779 64456 65240 64930 64561 65272 65353 64118 73490 66021 66095 66851 66404 66127 65711 64154 64565 64568 64369 64929 65574 64591 64634 73461 65609 64651 65365 64686 73428 65109 65845 73455 64449 65970 73191 64971 65342 64636 64113 64501 65710 66377 66308 65595 64236 65003 64114 64171 64347 66792 66221 64310 73513 64104 64145 65557 66356 66381 66812 73368 65829 66921 64735 66321 73035 66692 65390 65045 64757 64273 65833 65848 73297 66982 65043 64791 73182 65258 65583 65586 66612 65931 64637 66010 66623 65303 66012 66422 66457 66502 64181 64214 65154 66490 64091 65079 73122 65225 64308 64765 66594 64632 66923 65414 65459 73253 73337 73375 65529 64732 66253 66579 73153 64822 65659 73545 64265 66178 65345 65391 66288 65063 64122 64392 64484 66757 66760 65439 66529 66679 66907 65814 66616 64199 64649 65760 64085 64496 66335 65136 64491 65434 64087 65148 65513 65017 66813 66009 64569 73162 65709 73262 64271 65798 65753 64681 66695 64385 65909 73241 66878 65539 65948 64806 65048 65455 66861 64177 73320 66873 65347 65392 65138 64563 64304 66606 73471 64168 64315 64452 65665 73160 65316 65125 64245 66041 66076 66536 64019 66375 66689 66407 65398 65493 65332 65618 64258 65880 64566 64504 65607 65693 66917 73558 65170 65956 66034 66112 66081 64583 66023 64212 64470 65257 64845 64890 66510 64708 64876 64879 64882 65301 64847 66603 65341 64292 65327 66080 66403 66596 65686 66470 66109 65805 65734 66517 64243 66223 66540 66630 65397 66605 65419 64064 66280 64914 65338 65146 64956 64189 66859 64297 65995 73244 64272 73546 65952 64384 65000 66872 66758 66664 73478 64378 65672 66824 66738 73442 64077 66017 73504 73413 64370 64409 64723 66230 65305 73514 64202 64340 73464 64105 66445 65667 73538 73547 66677 65972 64771 65046 73420 64247 64986 65032 65427 65878 66462 64902 64758 73185 73268 66762 73521 73522 64844 66316 66116 65906 64805 65683 73261 73357 73430 66927 66073 65040 64927 65469 65591 65694 65743 65830 64577 66303 73574 66771 66123 65135 65173 66466 65210 66694 65368 65903 65289 64343 66072 73061 64314 64450 66425 65528 64431 64071 64140 66634 65998 64827 73151 65652 66959 73225 64906 66828 64390 66014 66177" } ] }