SOMATOM Definition AS-Computed tomography system
Medical device recall Z-0473-2022. Published in FDA’s Enforcement Report on Jan 19, 2022.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jan 19, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 794 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
SOMATOM Definition AS-Computed tomography system Model 8098027
794 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,997 characters
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…
FDA’s list runs to 4,805 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 19, 2021.
- FDA classified it on Jan 10, 2022.
- FDA’s Enforcement Report published it on Jan 19, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Siemens Medical Solutions USA, Inc, of Malvern, PA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 4,805 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.