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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88888

7 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 30, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Siemens Medical Solutions USA, Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

7 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 7

SOMATOM Force with software syngo.CT VB20 Model #10742326

Z-0283-2022
Recall number
Z-0283-2022
Initiated
August 30, 2021
Classification
Class II
Status
Terminated
Quantity
232 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur

Code information

Serial Numbers: 75708 75765 76356 76406 75550 75879 76211 76294 75714 75790 75709 76019 75949 76166 76175 76170 76156 76162 76169 75607 76186 94851 75984 75784 76397 76221 75789 76326 75617 75526 76199 75512 75775 75567 76298 76279 75536 75807 76379 76408 76231 76232 75711 75716 75514 76353 75875 75899 75770 76152 75600 76357 75994 75563 76046 76089 75794 76366 76374 76193 75974 76059 76196 75897 76241 75510 76274 76292 76343 75892 75792 75535 75820 75754 75755 75993 75916 75971 75893 75944 75923 75540 76027 76362 76454 75739 75980 76217 76091 76101 75571 75848 76329 75818 76138 75850 75973 75437 75500 75527 75953 75885 76074 76385 75728 76142 76205 76064 76337 76090 76405 75939 75475 76147 75877 75727 76163 76057 75481 75439 75776 75450 75482 76237 75760 76403 75710 76056 76080 76118 75806 75808 76114 75588 75476 75931 76228 75890 76320 76203 75493 75900 76387 75528 75467 75823 76332 76334 75454 76003 75761 76207 75814 76416 75906 76097 75602 75487 76248 75837 75787 75743 75793 76010 76061 76202 76208 76441 75478 76415 76041 75936 75959 76275 75905 76293 76440 75942 75941 75604 75805 75513 76377 75884 76439 76006 75867 75532 75919 76140 76050 75913 76190 76181 76424 75843 76016 75983 75460 75555 76418 76368 76168 75524 75778 75515 76411 75610 75559 75501 75570 75769 76189 75774 76280 75849 76236 75788 76000 76073 75752 75999 75976 76008 75616 75750 76258 75576 75845 75852 75605 76001

Distribution pattern

US Nationwide distribution.

device · product 2 of 7

SOMATOM Definition AS with software syngo.CT VB20 Model #8098027

Z-0284-2022
Recall number
Z-0284-2022
Initiated
August 30, 2021
Classification
Class II
Status
Terminated
Quantity
665 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur

Code information

Serial Numbers: Serial Number 96278 96887 66027 64492 64541 64519 64427 67297 95303 96267 67241 64798 98423 65597 95389 96689 64419 64347 64860 64382 64869 65238 66734 92078 95804 96471 95889 95778 92353 95847 95936 67236 65852 95798 96466 95363 64927 98354 95934 96279 95807 95602 95639 95985 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 66611 92056 92261 92342 95684 66319 95545 96547 95702 95766 67218 67128 64859 95788 96491 65370 95234 95466 95809 95616 59819 66032 95372 95461 95043 66087 95582 95143 67363 65768 92186 96941 95951 95100 98422 98413 66600 66844 66649 66635 95299 66225 66842 66916 95584 95151 66188 66355 64022 92375 95578 98417 64498 64763 64372 65788 66150 66933 96472 98366 65299 66461 66604 65115 66441 96948 95196 92184 92131 65515 66498 96380 66197 66688 66164 95777 65769 95609 96424 96020 95742 92298 64825 96413 96015 96824 65770 59825 64066 66201 66406 66574 96529 95856 96544 65713 66700 65926 66503 98404 65443 96305 95881 95845 98364 96845 65804 95280 96773 96455 66126 65478 96726 95095 96370 98445 95940 95784 98403 65407 65251 64720 92335 92300 66969 96750 96530 64685 96038 96863 95175 95457 95459 65403 96341 66542 95465 92358 96984 67175 65740 66690 95451 67326 95274 95875 95983 67380 65555 65291 66151 95891 66557 96633 66148 96335 95892 67288 92180 66705 96823 65418 95152 96421 67133 67048 95411 64677 67319 95960 64740 59820 98441 66019 66062 92023 96014 65501 66234 98449 98357 95893 65927 65186 95659 95193 98363 96709 96351 95413 96385 95848 98359 96785 156012 66478 66850 92053 95437 96346 95272 64218 95207 95393 96893 96438 66999 95846 96369 95485 96316 96028 66011 95647 67391 96812 65818 96418 95344 92321 66618 96288 66396 96238 95080 96676 92101 96352 96444 92313 96271 95710 96336 96324 67229 67010 67108 95438 95439 95751 65611 67126 65936 66958 65709 65556 92033 92296 96312 95906 96896 96021 92254 65735 95768 95715 91964 64489 64732 98401 66183 92169 65793 96937 95968 98447 64051 95014 65728 96832 66587 95425 67291 95415 64729 65235 64999 98411 66232 98350 66290 65229 65925 95818 64060 95661 65455 64960 66173 96929 66808 96697 65844 95339 95022 95748 95199 65779 96553 96303 95034 66021 66095 65151 96828 67312 96338 95302 64568 59828 65610 64248 67169 67193 96545 64707 66237 64096 98353 95952 65079 65831 95868 96991 96942 92336 96899 64501 66308 95378 96266 66792 95737 67274 96922 95912 65808 92207 92125 95361 65800 95961 95701 95376 96328 65371 92315 66356 66381 96713 95580 66812 64572 64967 65022 64052 65795 67036 95427 65173 64407 65848 66930 95782 95938 67251 95972 66116 95192 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 66931 66288 59824 98442 59822 96736 98414 95678 64247 66529 96541 64322 95342 96983 64148 65760 65865 66265 66335 65854 95786 66813 96909 98352 59812 96440 98409 95592 66081 64924 64934 66082 65909 64813 59814 95221 95703 92108 65347 65392 92091 66925 95087 96717 92176 95517 98362 67232 96821 66536 66041 64019 66689 95441 66407 96857 95484 65493 95521 95059 95359 65607 65803 65956 64160 64605 64064 95021 95013 95499 64675 92189 96538 96668 95498 95147 98452 95808 66403 92409 91968 92000 66470 65805 95575 96049 96040 95591 92323 66223 66540 96268 59815 67192 66630 95719 66280 95079 64908 65247 96740 66859 65995 67321 95797 95758 95145 96864 96281 66664 65667 96058 65157 96463 95440 95549 66434 66017 96302 95523 66445 95674 65773 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 95195 92069 95640 98421 67167 95510 66771 95635 96695 65777 66860 66694 96062 95914 95657 95513 66425 96275 96003 95529 98418 98419 64785 65652 66959

Distribution pattern

US Nationwide distribution.

device · product 3 of 7

SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000

Z-0285-2022
Recall number
Z-0285-2022
Initiated
August 30, 2021
Classification
Class II
Status
Terminated
Quantity
298 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur

Code information

Serial Numbers: 155403 84012 83047 83095 83915 83801 155351 155353 83826 83754 83904 155521 83632 83743 155578 83931 83979 155393 155396 155413 155489 83238 83336 83984 83401 84006 83834 83562 155341 83564 83582 155606 83596 155596 155485 155437 83934 83746 83234 83971 155573 155335 155422 83332 155459 155382 83994 83026 83330 155501 155535 83281 83767 155600 83880 83683 155360 155361 155564 83339 155580 83244 155615 83585 83899 155504 155315 83852 83226 83271 83607 84011 155405 83403 83599 155373 83937 83246 83388 83668 155343 155554 155399 83837 83591 83878 83714 155463 155447 83574 83567 83832 83886 83662 83763 83308 155312 83871 83375 83988 83227 83359 83031 155364 83520 83262 155502 84019 83903 83901 155524 84024 155513 83798 83292 83083 83096 83243 83319 83294 83544 83637 83640 83705 83707 155354 155507 83581 83717 83056 83950 155559 83382 83819 83363 83307 155388 84020 83732 83752 155581 155584 155569 155427 83961 155329 83845 83236 155318 83348 155374 155365 83846 83399 155601 83749 83847 155322 83786 155300 83975 84016 155389 83914 83842 83775 83084 83004 155358 155443 155304 83014 83573 155515 83796 83274 94801 83768 83684 83552 83210 84001 83537 83233 83352 83569 155532 83711 83697 155572 83991 83395 155357 155356 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 83680 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 83823 155434 155309 155386 155570 83611 83633 83985 155380 83967 83589

Distribution pattern

US Nationwide distribution.

device · product 4 of 7

SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603

Z-0286-2022
Recall number
Z-0286-2022
Initiated
August 30, 2021
Classification
Class II
Status
Terminated
Quantity
121 unit

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur

Code information

Serial Numbers: 73917 73531 73126 98623 73066 74909 73152 73760 98602 98603 73476 73726 73586 73937 98616 74206 73544 73648 74156 73636 74207 73813 74360 73054 74128 73427 98600 73622 73621 73424 73423 73493 73520 73718 73296 73471 73786 74374 98620 73831 74042 74191 74405 74117 74118 73673 73497 74929 73409 73935 73642 74240 73657 73090 73030 73013 73300 73499 73535 73655 73355 73036 73908 74978 73008 74391 74209 73490 73059 73758 73513 98632 98630 74094 74098 73895 73141 74262 74158 74153 74192 73670 73051 73360 74226 74297 74234 74364 73162 73683 74068 73320 73635 73405 73547 73931 73135 73818 73873 73266 73197 74511 73591 98642 73905 73225 73938 98605 73443 74922 73886 73413 73445 74129 73261 74093 74251 73348 73430 73574 74152

Distribution pattern

US Nationwide distribution.

device · product 5 of 7

SOMATOM Drive with software syngo.CT VB20 Model #10431700

Z-0287-2022
Recall number
Z-0287-2022
Initiated
August 30, 2021
Classification
Class II
Status
Terminated
Quantity
75 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur

Code information

Serial Numbers: 105081 105478 105152 105471 105315 105484 105182 105228 105207 105128 105123 105241 105105 105020 105063 105035 105022 105045 105052 105150 105485 105302 105472 105096 105477 105047 105023 105180 105115 105086 105295 105398 105051 105196 105445 105336 105383 105402 105202 105046 105109 105244 105498 105466 105461 105165 105060 105464 105103 105121 105141 105344 105066 105503 105118 105321 105184 105245 105339 105240 105507 105280 105440 105254 105403 105354 105427 105208 105012 105116 105363 105294 105080 105018 105237

Distribution pattern

US Nationwide distribution.

device · product 6 of 7

SOMATOM Confidence with software syngo.CT VB20 Model #10590100

Z-0288-2022
Recall number
Z-0288-2022
Initiated
August 30, 2021
Classification
Class II
Status
Terminated
Quantity
104 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur

Code information

Serial Numbers: 100172 100091 100112 100362 100278 100158 100143 100129 100237 100238 100191 100356 100425 100216 100307 100325 100328 100329 100326 100239 100213 100070 100062 100072 100022 100107 100241 100157 100055 100340 100347 100137 100267 100190 100252 100438 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 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 100140 100085 100279 100254 100353 100298 100379

Distribution pattern

US Nationwide distribution.

device · product 7 of 7

SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000

Z-0289-2022
Recall number
Z-0289-2022
Initiated
August 30, 2021
Classification
Class II
Status
Terminated
Quantity
64 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur

Code information

Serial Numbers: Serial Number 122022 122098 122062 122099 122121 122146 122054 122082 122080 122020 122164 122116 122008 122036 122029 122044 122172 122074 122075 122049 122141 122167 122156 122081 122126 122129 122090 122130 122089 122085 122037 122009 122163 122064 122038 122161 122168 122158 122144 122063 122086 122035 122041 122114 122107 122101 122108 122109 122162 122125 122011 122052 122034 122057 122145 122147 122106 122061 122051 122166 122170 122092 122004

Distribution pattern

US Nationwide distribution.