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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Siemens Medical Solutions USA, Inc: Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.

Agency Publication Date: January 10, 2022
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Affected Products

Product: SOMATOM Confidence -Computed tomography systems Model 10590100

Serial Numbers: 100172 100091 100112 100362 100278 100158 100143 100129 100237 100238 100191 100356 100425 100216 100307 100325 100328 100329 100326 100239 100461 100213 100070 100062 100072 100022 100107 100241 100157 100055 100340 100347 100137 100267 100190 100252 100438 100046 100197 100092 100202 100313 100311 100043 100136 100189 100283 100156 100079 100049 100056 100147 100262 100018 100240 100117 100097 100274 100242 100099 100383 100059 100289 100312 100174 100073 100016 100182 100146 100058 100170 100175 100292 100090 100271 100463 100257 100273 100067 100160 100218 100367 100087 100309 100284 100207 100405 100261 100025 100338 100272 100053 100019 100421 100280 100357 100220 100214 100393 100394 100486 100140 100085 100279 100254 100353 100298 100379 UDI: UDI 04056869011011

Product: SOMATOM Definition AS-Computed tomography system Model 8098027

Serial Numbers: 96278 96887 66027 64492 64541 64519 64427 67297 95303 96267 64864 96211 59802 67241 64798 98423 65597 95389 96689 64419 64347 64860 64382 64869 65238 66734 92078 95804 96471 98402 95985 96710 95889 95778 92353 95847 95936 67236 64464 64471 65852 95798 96454 96466 95363 64927 91966 98354 95934 96279 95807 95602 95639 65288 64773 95229 65297 65159 64036 95628 66143 64317 95610 98474 95859 95939 95601 95070 95882 95596 95791 66219 65752 98356 95677 64104 66506 66312 95844 95670 66858 65382 98424 66588 92280 67399 64413 64559 64235 66611 92056 92261 92342 95684 66319 95545 96547 95702 95766 67218 67128 64859 95788 64487 96491 65370 95234 95466 95809 67098 95616 59819 66032 95372 95461 95043 66087 95582 95143 67363 96950 65768 92186 96941 95951 95100 98422 98413 66600 64030 66844 66649 66635 95299 66225 66842 66916 95584 95151 66188 66355 64022 92375 95578 96777 66467 98417 64498 64763 64372 95362 65788 65015 66150 96647 66933 96472 98366 65299 66461 66604 65115 66441 96948 95196 92184 92131 65515 66498 96380 96973 66197 66688 66164 95777 65769 95609 96424 96020 66768 65304 67233 95742 92298 64825 96413 96015 96824 65770 59825 67310 64066 66201 66406 66574 96529 95856 96544 65713 66700 65926 66503 98404 65443 96305 95881 95845 98364 96845 65804 95280 96773 96455 66126 65478 95923 95903 96747 67116 96726 95095 96370 98445 95940 64516 95784 98403 65407 65251 64720 92335 92300 66969 96750 96530 64685 66001 96038 96863 96992 95175 95457 95459 66928 65403 96341 66542 95465 92358 96984 67175 65740 66690 95451 67326 95274 95875 95983 67380 65555 64709 65291 66965 66151 67181 95891 64314 95181 66557 96633 96543 96669 66148 96335 95892 67288 67085 64446 92180 66705 96823 65418 95152 96421 67133 67048 95411 64677 67319 95960 64740 59820 98441 65755 66019 66062 92023 96014 96865 65501 66234 64221 98449 98357 95893 65927 65186 95659 59803 95193 98363 96709 96351 95413 64211 96385 95848 98359 96785 156012 66478 66850 96443 96749 92053 95437 96346 95272 64218 95207 64480 64947 95393 96893 96438 66999 95846 64463 65283 96369 95485 64835 64913 64834 64942 96316 96028 92243 66011 95647 67391 96812 66297 65818 96418 95344 92321 66618 96288 66396 96238 95080 96676 92101 96352 96444 92313 92177 96271 66473 66423 66304 66349 67010 67108 95438 95439 95751 95710 96336 96324 67229 65611 67126 65936 66958 65709 65556 92033 92296 96312 95906 96896 96021 92254 65735 95768 95715 91964 64489 64732 92169 98401 66183 65793 96937 95928 95968 98447 64051 95014 65728 96832 64282 95174 64031 66587 66789 64056 95425 67291 95415 64729 65235 64999 98411 66232 98350 66290 65229 96226 92132 65925 65148 95818 64060 95661 65455 64960 96340 66173 65145 64110 96929 66918 66808 96697 66843 92347 92307 65844 95339 95022 95748 95199 65779 96553 96303 65272 95646 95034 66021 66095 99401 96022 65151 96828 67312 96338 95302 64568 59828 65610 64248 96023 67169 67193 96545 64602 64707 66237 64096 98353 95952 65079 65831 92087 95868 96991 96942 92336 96899 64501 66308 95378 96266 65003 66792 95737 67274 96922 95912 65808 92207 92125 95361 65800 95961 95701 95376 96328 65557 65371 92315 66356 66381 96713 66821 95580 66812 64572 64967 65022 64052 65795 66221 67036 95427 65173 64407 65848 66930 66077 95782 95938 67251 95972 66116 95192 96851 65586 96250 96776 96347 96310 92058 64998 66457 66502 65154 66490 92088 95785 92099 92288 95522 64238 66110 59823 59829 64094 65659 66248 98473 66579 64796 64500 96425 95493 96061 96861 95593 64983 66931 66288 59824 98442 59822 96736 98414 95678 64247 66529 96541 92113 64322 95342 96983 64148 65760 65865 66265 66335 65854 95786 96524 65017 66813 96925 96909 98352 59812 96589 96440 98409 95592 66081 64924 64934 65701 66082 65909 64813 59814 96677 95221 95703 92108 65347 65392 92091 66925 95087 96717 92176 95517 98362 67232 96821 66076 66536 66041 64019 64767 66689 95441 66407 96857 95947 95484 65493 95521 95059 95359 65365 65803 65956 96837 64160 64605 64064 95021 95013 66023 95499 96967 64675 92189 96538 96668 66510 95924 95498 95147 98452 95808 66403 92409 91968 92000 66470 65680 65805 95575 96049 96040 95591 92323 66223 66540 96268 59815 67192 66630 95719 66280 95079 64908 65247 92057 95632 92208 92155 92165 96542 96740 66859 64297 95559 65995 67321 95797 95758 95145 96864 96281 66664 65667 96058 65157 96463 95440 95549 66434 66017 95577 96302 95523 66445 95674 65773 67083 156018 95642 95717 91996 92164 96053 66677 95520 96956 96011 95937 91974 66462 96327 96326 95402 96645 95025 96286 96700 96029 66882 91990 96604 95024 64196 65906 95927 96364 96397 67392 95886 65829 64712 64132 92045 65866 65743 65830 65694 65303 95195 92069 95640 98421 67167 95510 66771 95635 96695 65777 66860 66694 96062 65368 92098 95914 95657 65758 95513 66425 96275 96003 95529 98418 98419 64785 95716 65998 66447 65652 66959 UDI: UDI 04056869003665

Product: SOMATOM Edge Plus-Computed tomography system Model 1026700

Serial Numbers: 122022 122185 122098 122062 122099 122121 122146 122054 122082 122080 122020 122164 122116 122008 122036 122029 122044 122172 122074 122075 122049 122194 122141 122167 122156 122183 122081 122126 122129 122090 122130 122179 122089 122085 122037 122009 122163 122177 122066 122064 122038 122161 122132 122171 122153 122168 122158 122144 122063 122086 122035 122041 122112 122114 122107 122101 122108 122109 122162 122187 122174 122125 122178 122011 122182 122052 122034 122057 122145 122147 122050 122106 122189 122180 122061 122051 122166 122170 122092 122004 UDI: UDI 04056869006949

Product: SOMATOM Definition Edge -Computed tomography system Model 10590000

Serial Numbers: 155403 84012 83047 83095 83915 83801 155351 155658 155353 83826 83754 83277 83249 83904 155521 83632 83743 155578 83931 83979 155393 155396 155413 155489 83238 83336 83984 83401 84006 83834 155671 155649 83562 155341 83564 155613 83582 155606 83596 155596 155485 155437 83934 83746 83234 83971 155573 155335 83321 155422 83332 155459 155382 83994 83026 83330 155501 155639 155535 83281 83558 83767 155600 83880 83683 155360 155361 155564 83339 155580 83244 155615 83585 83899 155504 155315 155592 83613 83852 83226 83271 83607 84011 155405 83403 83599 155373 83695 83937 83246 83388 83668 155642 155343 155554 155399 83584 83837 83591 155616 83878 83714 155463 155447 155630 83574 155318 83567 83832 83886 83662 83763 83308 155312 155557 83871 83375 83988 155629 155637 83227 83359 83031 155364 83520 83262 155502 155627 84019 83903 83901 155524 84024 155513 83798 83292 83243 83319 83294 83544 83637 83640 83705 83083 83096 83707 155354 155507 83581 83717 155634 155632 83728 83056 83950 155559 83382 83819 83041 83363 83307 155388 84020 83732 83752 155581 155584 155569 155427 83961 155329 83845 83236 83348 155374 155365 83846 83399 155601 83749 83847 155322 83786 155300 155636 83975 84016 155389 83914 83842 83775 83084 83004 155358 155623 83669 155443 155304 83014 83573 155655 155515 83796 83274 94801 83768 155575 83684 83552 83210 84001 83537 83233 83352 83569 83909 155532 83968 155348 155585 83711 83697 155572 83991 155668 83395 155356 155357 155660 155442 155582 155342 155530 83621 83859 83335 83278 83742 83018 83322 83392 155558 155350 83279 83276 83365 83970 83928 83015 83093 83327 83091 83946 83207 83938 155316 83230 83254 83680 83708 83945 155594 155621 155605 83291 155549 155328 83203 83214 83913 83896 155583 155614 83790 83875 155553 83232 83362 83824 83306 83542 84010 155384 155448 155506 155412 155493 83942 83941 84017 83981 155566 83257 155576 155495 83057 83539 83810 155579 83758 155497 83239 83398 83565 83313 83653 83957 83347 83349 84027 83323 83739 155369 83266 155510 83522 83898 83951 83387 155400 83733 155407 155371 155638 83823 155434 155309 155653 155386 155570 83611 83633 83985 155380 83967 83589 UDI: UDI 04056869006949

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89208
Status: Active
Manufacturer: Siemens Medical Solutions USA, Inc
Manufactured In: United States
Units Affected: 3 products (108 units; 794 units; 80 units)

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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.