Is AXIOM Artis FC, Model Number 5904433 recalled?

Medium RiskFDA Device

Siemens Medical Solutions USA, Inc: A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.

Agency Publication Date: July 22, 2019

Affected Products

Product: AXIOM Artis FC, Model Number 5904433

Serial Numbers: 10436 10444 10425 10433 10435

Product: AXIOM Artis FA, Model Number 5904441

Serial Numbers: 25328 25349 25382 25403

Product: AXIOM Artis MP, Model Number 5904466

Serial Numbers: 20334 20052 20303 20238 20242 20322 20282 20363 20338 20295 20348 20172 20264 20367 20258 20265 20250 20249 20281 20243 20339 20321 20294 20254

Product: AXIOM Artis BC, Model Number 5904649

Serial Numbers: 14101 14111 14108 14099 14094 14112

Product: AXIOM Artis BA, Model Number 5904656

Serial Numbers: 28159 28144 28154 28139 28155 28160 28156

Product: AXIOM Artis dBC, Model Number 5917054

Serial Numbers: 49008

Product: AXIOM Artis TA, Model Number 7007755

Serial Numbers: 32090 32085 32091 32094 32095

Product: AXIOM Artis dTA, Model Number 7008605

Serial Numbers: 55163 55713 55304 55435 55567 55407 55412 55310 55470 55164 55187 55206 55091 55059 55204 55377 55307 55171 55368 55210 55133 55135 55477 55250 55318 55196 55230 55277 55423 55320 55387 55576 55438 55503 55046 55308 55139 55039 55270 55188 55314 55381 55550 55365 55574 55415 55109 55337 55322 55272 55157 55234 55548 55282 55575 55211 55410 55150 55079 55262 55259 55531 55388 55275 55276 55254 55569 55177 55269 55292 55041 55404 55425 55183 55441 55125 55369 55437 55136 55356 55191 55103 55400 55483 55083 55526 55088 55243 55056 55408 55715 55233 55416 55256 55074 55212 55153 55325 55312 55273 55213 55401 55170 55284 55469 55067 55048 55216 55241 55708 55202 55461 55154 55167 55342 55468 55219 55553 55217 55386 55396 55513 55279 55414 55347 55042 55294 55160 55286 55036 55362 55436 55375 55131 55062 55107 55411 55052 55096 55156 55289 55374 55705 55017 55223 55149 55141 55089 55305 55078 55227 55040 55200 55186 55184 55232 55358 55222 55313 55085 55090 55324 55045 55382 55350 55353 55405 55043 55439 55473 55070 55545 55434 55118 55455 55263 55274 55238

Product: AXIOM Artis dFC, Model Number 7412807

Serial Numbers: 37701 35374 35937 35456 35327 35368 35432 35690 35301 35451 35553 35427 35743 35750 35762 35778 35788 35764 35736 35350 35369 35601 35664 35730 35783 35376 35714 35547 35325 35314 35522 35635 35660 35333 35511 35536 35560 35329 35655 35810 35335 35353 35359 35410 35599 35556 35361 35283 35828 35380 35893 35351 35815 35306 35390 35525 35921 35727 35441 35465 37702 37713 35182 35974 35704 37705 35269 35339 35345 35516 37709 35486 35431 35512 35739 35834 35535 35305 35326 35471 35472 35334 35577 35202 35279 35860 35600 35309 35684 37710 35663 35346 35789 37715 35649 35615 35665 35768 35945 35312 35423 35241 35253 35610 35291 35629 35836 35603 35916 35707 35728 35698 35402 35571 35583 35666 35550 35821 35406 35626 35240 35668 37700 35540 35518 35179 35249 35504 35562 35566 35567 35501 35502 35623 35490 35545 35476 35709 35712 35744 35232 35452 35695 35678 35266 35793 35338 35784

Product: AXIOM Artis dTC, Model Number 7413078

Serial Numbers: 46022 46023 46154 46107 46263 46091 46203 46100 46025 46034 46042 46063 46036 46245 46062 46198 46169 46272 46117 46051 46137 46157 46215 46216 46219 46220 46221 46108 46040 46124 46126 46225 46226 46120 46152 46223 46130 46241 46213 46128 46205 46231 46098 46133 46271 46060 46085 46201 46182 46122 46065 46143 46144 46186 46097 46111 46067 46138 46269 46054 46125 46194 46190 46168 46180 46044 46127 46204 46112 46115 46118 46150 46164 46103 46113 46270 46178 46047 46106 46156 46202 46167 46163 46045 46158 46210 46179 46256 46192 46176 46170 46171 46174 46101 46139 46061 46035 46239

Product: AXIOM Artis dBA, Model Number 7555357

Serial Numbers: 53181 53023 53167 53104 53067 53093 53162 53706 53058 53098 53253 53016 53188 53209 53223 53700 53017 53114 53063 53219 53033 53142 53116 53002 53086 53195 53165 53076 53064 53124 53176 53078 53111 53227 53202 53133 53140 53047 53710 53190 53180 53128 53185 53170 53187 53019 53141 53084 53074 53225 53215 53189 53056 53166 53149 53020 53096 53009 53147 53070 53049 53261 53122 53065 53031 53085 53026 53222 53090 53075 53256 53045 53057 53103 53182 53012 53022 53175 53194 53102 53109 53260 53043 53160 53117

Product: AXIOM Artis dMP, Model Number 7555365

Serial Numbers: 57204 57089 57077 57024 57144 57189 57208 57035 57188 57073 57072 57016 57009 57050 57207 57111 57171 57113 57193 57008 57198 57155 57124 57004 57105 57098 57116 57045 57156 58701 57183 57187

Product: AXIOM Artis dFA, Model Number 7555373

Serial Numbers: 50063 50059 50006 50064 50189 50044 50074 50101 51719 50062 50065 50087 50167 50039 50084 51706 51707 50048 50161 50093 50206 50057 50081 50133 50040 50016 50120 50191 51701 50027 51700 50139 50004 50010 50024 50142 50079 50132 50050

Product: AXIOM Artis dFC, Model Number 7727717

Serial Numbers: 40072 40031 40075 40070 40032 40067 40064 40065 40061 40017 40066 40071 40059 40038 40029 40039 40048 40073 40062

Product: AXIOM Artis TC, Model Number 7728350

Serial Numbers: 30006

Product: AXIOM Artis dBC, Model Number 7728392

Serial Numbers: 44125 44151 44101 44246 44185 44262 44263 44199 44105 44084 44080 44072 44243 44198 44171 44275 44215 44255 44081 44242 44265 44189 44289 44145 44060 44144 44184 44286 44223 44068 44193 44244 44201 44251 44229 44304 44152 44136 44254 44277 44279 44268 44206 44278 44259 44260 44168 44267 44110 44218 44165 44271 44135

Product: Artis zee floor, Model Number 10094135

Serial Numbers: 135944 135746 135120 135322 135757 136513 136562 135914 135102 136042 135927 135986 135935 135953 135841 135200 135201 135279 135169 135879 135229 135157 136113 135990 136077 136103 135862 135235 135117 135358 135920 136168 135148 135366 136568 135843 135111 135112 135779 136224 135137 136607 136579 135309 124007 124015 136280 136286 135109 135413 135144 135145 136362 135404 136318 136234 135151 135421 135264 135199 135760 136500 136515 135217 136031 136032 135124 135125 136084 136026 136479 135179 135394 135285 136338 136196 135245 135420 136384 136387 136488 135770 136550 136256 136408 136450 136508 136547 135788 136242 136383 136517 135406 136043 136586 135129 135416 135909 135222 136393 136520 135258 135260 135755 136548 135143 135114 135133 136350 135353 135253 135375 135772 136483 136555 135190 135881 136614 137384 136567 135714 135922 136314 136190 136197 136254 135813 135791 136561 135302 135152 136505 135182 124006 135868 135793 135132 135723 136126 135847 135281 135373 135196 136128 136147 136557 136558 136391 136503 136143 135352 135388 135384 136582 136345 136570 135954 136459 136518 135771 136290 136609 135233 136594 135203 136137 135286 135397 136278 135424

Product: Artis zee ceiling, Model Number 10094137

Serial Numbers: 146669 146877 146996 146663 147100 146286 146292 146410 146676 147155 147049 147233 146406 146407 146411 146121 146710 146945 147084 147189 147190 146679 146766 146232 146408 146409 146728 146335 146659 146993 146898 146965 146221 147273 146814 146871 146952 147030 147239 146988 146899 146368 146643 146650 146980 146361 146365 146366 146369 146912 147036 146116 146164 146168 147079 147371 146156 146342 146343 147129 146192 147081 146235 146201 146260 146277 146868 146758 146818 146741 146174 147507 146245 147047 125002 146171 146173 146176 146186 146187 146188 146189 147042 146630 146266 146305 146908 146267 147208 147247 146219 146272 146274 147096 125022 147236 146193 146761 147175 146298 146637 146972 147078 146976 146652 146327 146333 146338 147786 147023 146851 147249 147255 146688 146166 146144 147165 147188 146324 146715 146293 146308 146968 147105 146825 146827 146828 146829 147304 146937 146946 147024 146334 125005 146322 146888 147172 146136 146738 146795 147164 146395 147378 147087 146742 146169 146856 146921 146263 146781 146721 146724 146860 146393 147035 125009 147193 147196 146986 146323 146150 146812 146241 146242 146635 147025 146354 147044 146251 146727 146238 146388 146382 147814 146753 146755 146756 147203 146119 146264 146618 147098 146139 147113 146656 147107 146942 146886 147167 146733 147121 146612 147106 146731 146809 146394 146846 146855 146940 146957 147243 146918 146709 147831 147119 147120 147124 146901 147144 147237 147240 146863 146934 146806 146935 147268 146798 147168 147029 125004 146619 146205 146803 147285 146722 146717 146774 146690 146691 146218 146987 146786 146424 146983 146152 146975 146137 146279 146289 146750 147296 147171 146184 147210 146775 146776 146969 146971 146973 147200 146345 147067 125016 147059 147177 146872 146784 146932 146397 147238 146887 147241 146711 147089 146233 146170 146220 146919 146257 147009 146183 147114 146839 146178 147214 147216 146963 147373 147123 146212 146895 146909 146627 146712 146740 147174 146713 146320 146175 146179 146181 146182 147083 146337 146861 146939 146696 146104 146948 146964 146729 146313 146158 146959 146147 146759 146779 146735 146991 146732 146857 146748 147088 146254 146631 146905 146111 146161 125003 146123 146197 147093 147264 147364 147075 125000 146869 147043 146623 146634 146960 146896 147027 146701 146703 146720 146747 146994 146370 146372 146373 146982 146386 146340 146217 147287 146256 146302 146341 146234 146667 147205 147250 147251 147252 147253 147254 146239 146933 146348 146697 146925 146929 146801 146719 146138 147363 147372 146692 146694 147157 146206 146391 146658 146357 146632 146927 147207 125015 147234 146883 146297 146352 146793 146915 146290 147295 146811 147046 146287 146326 146644 146944 146821 146833 146398 146427 146677 147307 146705 147103 147303 147265 147301 147235 146881 147094 146714 146107 146700 147031 146118 146149 146299 146698 146817 146797 146782 146977 146780 146928 147109 146155 146955 146140 146866 146867 147186

Product: Artis zee multi, Model Number 10094139

Serial Numbers: 157435 157509 157660 157710 157458 130017 157698 157532 157449 157657 157136 157690 157616 157560 157436 157677 157528 157503 157615 157448 157165 157700 157602 157168 157642 157213 157164 157559 157156 157524 157588 157750 157579 157573 157650 157671 157554 157555 157521 157696 157488 157644 157648 157169 157668 157508 157510 157601 157139 158058 157536 157625 157600 157604 157565 157634 157635 157146 157583 157476 157497 157570 157658 157505 157594 157706 157586 157674 157414 157215 157692 157707 157507 157708 157544 157184 157659 157661 157531 157409 157688 157702 157704 157466 157442 157667 157438 157440 157645

Product: Artis zee biplane, Model Number 10094141

Serial Numbers: 153131 153229 153172 153315 153317 153992 153335 153695 153101 153102 153717 153779 153280 153648 153674 153166 153700 154096 153834 153194 153169 153803 153110 153890 154157 153199 153887 153269 154074 154012 153191 153252 153732 153239 154090 153227 153889 153655 153234 153236 153285 154686 153273 153251 153254 153344 154095 153342 154093 153171 153197 153916 153831 153256 153154 154086 153139 153882 153311 153211 153118 153987 153740 153863 153772 154079 153965 153707 154098 154073 153263 153276 154076 153758 131013 153257 154156 153351 153112 153155 153245 153318 153720 153998 153271 153857 153226 153939 153951 153290 153678 153679 153277 153125 153128 153134 153135 153743 153967 153946 153145 153866 153868 153829 153148 131021 153878 153906 153959 153709 153767 153217 153639 153119 153164 153304 153869 153719 153232 131005 153770 154020 153930 153728 153355 154058 153811 153225 154155 153883 153875 153289 153664 153963 153824 154034 154018 153356 153701 153113 153235 153347 153708 153338 154066 153259 153314 154014 153988 154048 153716 153215 153922 153870 153107 153178 153249 153706 153860 153264 153157 153903 153908 153819 154087 153914 154085 153156 153697 131000 153147 153790 153928 153864 153159 153756 153808 154052 153797 153634 154028 154084 153201 153865 153640 153714 153736 153832 153913 153348 153220 153947 153657 153873 153109 153150 153299 153757 153898 154075 154064 153111 153618 153689 154044 153847 154056 154035 153999 153124 153682 153120 153122 153329 153173 153763 153686 154100 154082 153617 153327 153180 153818 154007 153323 154055 154067 154088 131020 153762 153270 153862 153670 153607 153760 154094 153265 153694 153886 153332 153141 153195 153920 153343 153975 153993 153325 153631 153160 153186 153729 154089 153354 153684 153799 154041 153742 153952 154077 153214 153722 153206 153255 154097 153115 153744 153827 153671

Product: Artis zee floor MN, Model Number 10094142

Serial Numbers: 140212 140115 140101 140205 140213 140204 140209 140219 140224 140218 140221 140220 140206 140223 140105 140226 140108 140102 140109 140100 140202 140214 140114

Product: Artis zee biplane MN, Model Number 10094143

Serial Numbers: 149202 149100 149106

Product: Artis zeego, Model Number 10280959

Serial Numbers: 160395 160484 160502 160351 160392 160449 160463 160313 160411 160406 160106 160134 160136 160347 160312 160488 160448 160427 160455 160486 160435 160451 160346 160384 160100 160493 160391 160321 160376 160447 160471 160481 160401 160119 160403 160404 160501 160438 160388 160378 160419 160114 160450 160429 160149 160137 160152 160153 160154 160138 160446 160368 160394 160412 160387 160432 160147 160433 160483 160335 160402 160356 160425 160148 160337 160460 160485 160443 160461 160370 160381 160508 160122 160407 160325 160494 160390 160507 160144 160487 160418 160007 160001 160363 160341 160139 160430 160482 160006 160462 160520 160505 160445 160322 160323 160382 160421 160474 160116 160428 160131 160318 160357 160369 160498 160413 160414 160128 160373 160509 160551 160327 160338 160477 160519 160141 160469

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83203

Status: Resolved

Manufacturer: Siemens Medical Solutions USA, Inc

Manufactured In: United States

Units Affected: 23 products (5; 4; 24; 6; 7; 1; 5; 178; 148; 98; 85; 32; 39; 19; 1; 53; 170; 428; 89; 268; 23; 3; 117)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. 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. Refer to the openFDA terms of service for more information.