Siemens Medical Solutions USA, Inc: A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.

Agency Publication Date: February 20, 2020

Affected Products

Product: Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract.

Serial Numbers 5043 5085 5825 5234 5862 5751 5810 5188 5352 5719 5803 5812 5920 5921 5209 5069 5086 5151 5299 5372 5611 5037 5072 5947 5049 5190 5892 5961 5364 5163 5919 5355 5902 5690 5767 5954 5884 5278 5963 5956 5682 5953 5634 5951 5120 5962

Product: Luminos Agile Max, model no. 10762471 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract.

Serial Numbers 61203 61751 61085 61755 61858 61786 61795 61034 61127 61602 61212 61053 61194 61699 61757 61752 61200 61738 61799 61875 61603 61624 61885 61848 61243 61606 61682 61087 61888 61052 61889 61226 61854 61079 61218 61110 61137 61123 61763 61621 61622 61623 61788 61798 61837 61892 61193 61700 61743 61652 61229 61045 61838 61239 61632 61190 61013 61659 61102 61724 61063 61054 61784 61213 61651 61056 61088 61146 61681 61678 61873 61720 61716 61027 61021 61145 61824 61050 61210 61211 61240 61227 61185 61779 61140 61181 61061 61158 61242 61074 61209 61075 61686 61094 61032 61769 61608 61711 61869 61169 61223 61083 61234 61660 61661 61849 61143 61670 61616 61723 61754 61684 61249 61691 61130 61668 61806 61717 61174 61740 61722 61777 61126 61255 61855 61015 61183 61046 61804 61625 61731 61748 61845 61822 61863 61719 61829 61162 61125 61156 61713 61196 61028 61076 61787 61825 61683 61081 61758 61609 61618 61744 61111 61248 61704 61890 61656 61663 61636 61827 61159 61114 61635 61132 61112 61118 61253 61664 61177 61733 61040 61641 61646 61151 61238 61673 61831 61221 61832 61638 61207 61133 61695 61671 61631 61201 61833 61865 61148 61128 61815 61236 61828 61810 61839 61172 61116 61847 61168 61175 61662 61048 61171 61060 61649 61768 61042 61115 61813 61188 61191 61206 61708 61665 61746 61747 61862 61230 61667 61881 61113 61771 61044 61147 61096 61617 61035 61861 61134 61033 61066 61155 61224 61876 61157 61634 61844 61178 61882 61883 61182 61065 61801 61841 61874 61068 61069 61880 61674 61680 61830 61776 61736 61761 61186 61766 61783 61756 61772 61797 61793 61843 61614 61250 61251 61868 61219 61803 61753 61856 61107 61152 61093 61091 61014 61025 61208 61791 61256 61654 61173 61154 61189 61142 61165 61842 61734 61759 61718 61878 61840 61043 61781 61785 61601 61687 61647 61895 61897 61036 61669 61038 61739 61679 61857 61049 61022 61037 61098 61792 61215 61707 61153 61715 61894 61611 61120 61150 61633 61029 61884 61887 61072 61812 61879 61819 61187 61693 61800 61727 61696 61062 61820 61821 61725 61139 61141 61775 61080 61217 61689 61030 61778 61627 61018 61790 61222 61078 61086 61216 61195 61809 61039 61252 61860 61750 61721 61811 61807 61728 61202 61064 61163 61859 61835 61891 61077 61228 61871 61605 61767 61836 61826 61851 61630 61850 61896 61192 61690 61084 61823 61620 61749 61714 61770 61047 61121 61220 61729 61712 61225 61735 61802 61103 61628 61109 61198 61818 61626 61877 61247 61180 61644 61615 61244 61643 61705 61697 61742 61031 61097 61164 61166 61237 61245 61610 61612 61629 61655 61666 61672 61675 61676 61773 61780 61814 61160 61233 61741 61041 61055 61782 61057 61059 61067 61099 61100 61106 61258 61653 61852 61870 61017 61730 61765 61129 61246 61184 61604 61179 61677 61703 61774 61698 61864 61254 61073 61789 61131 61205 61872 61119 61637 61764 61051 61138 61866 61834 61619 61760 61122 61853 61816 61893 61613

Product: Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures f the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sit

Serial Numbers 24576 24077 25409 24100 24213 24051 24531 24542 24038 24116 25699 25698 25089 25076 25297 25477 25056 24644 24221 25717 25647 25716 24256 24572 25366 25425 25020 24616 24275 25444 24433 24536 24340 24437 24033 25392 25006 25554 25506 25644 25666 25164 25619 25156 25677 25038 25151 25152 24401 25125 25093 24291 25369 24622 24624 24629 24630 24635 24636 24637 24640 25375 24613 24244 24615 25672 24155 24159 24237 24343 25458 24381 24394 24402 25217 25192 25260 25669 24495 24502 24666 24430 24432 25629 25196 24052 25547 24128 24420 25600 24611 24450 24154 24156 25427 25154 25678 24059 24467 24612 24614 24505 25542 25098 25205 24299 25058 25246 24599 24600 25607 25371 25374 25380 25391 25397 25398 25404 24048 24099 25292 25250 24263 25569 25097 25105 24660 24662 24186 24187 25403 25416 25459 25497 24436 25414 25047 24113 25204 25109 24367 24463 24634 24641 25700 24297 24028 24283 25558 24590 25351 25280 25448 24496 25124 25095 25171 25512 24197 25565 24288 24289 24046 25509 25312 25463 25305 25096 24312 24408 25645 25284 25693 25715 24375 25104 25304 25510 25237 25244 25447 24190 24063 24284 24350 24441 24507 25694 25216 25082 25107 25060 24506 25077 25090 25053 25322 25389 25667 25668 25116 25440 25676 25679 25713 25714 25638 24442 25420 25474 24440 25439 25424 25051 25357 24083 25664 24225 25342 25675 24357 25670 24135 24172 25568 24558 24560 24327 24591 25031 25604 25426 24300 24592 25023 24131 25085 25531 25613 25119 25191 25471 24427 24470 25696 25697 25144 25493 25238 25402 24091 25370 24663 25456 25049 24174 25315 24625 24546 24551 24201 25143 25147 25225 25014 25009 25412 25683 25075 25165 25546 25256 25634 25436 25328 25592 24024 24656 24659 24574 25273 24543 25001 24504 24129 24277 25072 25015 25018 24103 24148 24424 24515 24571 24142 25199 24453 25228 25491 25492 25686 25219 25213 25240 25625 25695 25527 25587 25159 24480 25701 25501 25505 25507 25373 24304 25190 24214 25218 24082 25137 25691 25133 25655 25310 25673 25193 25517 25616 24478 25026 24182 25079 25083 25614 25624 25631 24014 24015 24026 24605 25518 25581 24109 24176 25208 25408 25588 25608 25665 25130 25330 25643 25630 25618 25710 24405 25617 25620 25262 24422 24435 25064 25571 25140 24034 24494 24049 24058 25054 25055 25057 24315 24373 24403 25585 24039 24234 24081 24114 25564 25576 25189 25301 25711 24090 25566 25709 25692 25149 24323 24406 24189 25117 25626 24272 25555 24222 24346 24347 24498 24484 25559 25385 25249 25254 25628 25690 24105 25706 24292 24294 24296 25348 24398 24610 25508 25302 25148 24226 25443 25445 25452 25454 24434 25329 25334 25648 25658 25010 24075 24580 25396 24025 24295 24468 25101 25247 25473 25478 25314 25685 25687 25688 25689 24251 25350 25712 24457 24458 24462 25367 25540 25197 24037 24053 24121 24230 24276 24582 24648 24655 25157 25236 25285 25361 25394 25574 24194 24404 25145 25150 25356 24479 25248 25702 25653 24087 24281 24581 25682 24293 25013 25017 25662 25561 25639 25642 25640 24481 25480 24561 25656 25704 25708 25313 25229 25230 25596 25365 24279 25169 25261 24285 25344 24348 25582

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84815

Status: Resolved

Manufacturer: Siemens Medical Solutions USA, Inc

Manufactured In: United States

Units Affected: 3 products (46; 475; 507)

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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.

Affected Products