SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system
Medical device recall Z-1745-2018. Published in FDA’s Enforcement Report on May 23, 2018.
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 May 23, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 3 states named
- 1385 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?
There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT scanners of types SOMATOM Definition AS, SOMATOM Definition DS, SOMATOM Definition Edge, SOMATOM Definition Flash and SOMATOM Force.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system
1385, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 96278 64789 64492 64541 65127 95804 98402 96795 64689 65442 64464 64471 96608 96666 65380 67102 66632 66767 65852 64870 64668 95258 96710 95889 67127 64239 65364 96428 64580 95798 96466 96649 98361 67120 95363 64278 64756…
Every code shown here, 1,996 characters
Serial Numbers: 96278 64789 64492 64541 65127 95804 98402 96795 64689 65442 64464 64471 96608 96666 65380 67102 66632 66767 65852 64870 64668 95258 96710 95889 67127 64239 65364 96428 64580 95798 96466 96649 98361 67120 95363 64278 64756 64800 64412 98354 95934 96279 65288 95054 96698 96479 64645 64725 95985 95229 64508 95854 98365 96379 95628 65339 65346 64714 95610 95939 95601 65831 65868 95596 95882 95791 64123 64246 65558 95859 65690 66219 64059 65752 98356 95677 95844 64658 95600 95670 66858 65491 96753 98424 67399 66611 64465 65076 95084 95998 64841 64454 95098 65762 95311 95604 96602 64485 64446 95684 64673 66319 95545 96547 95319 64419 95702 66518 65968 95332 95766 66168 65453 95650 96628 67218 67128 66640 66506 66312 64487 95788 95375 95234 95466 95809 64368 59818 64759 67098 98355 95616 95641 64477 64736 59819 64081 64117 64549 65175 65569 67145 64276 95372 95461 64916 95043 64112 66287 66292 64164 64180 66087 95582 95738 66764 95143 67363 65322 95777 96357 65768 65425 65810 65326 95819 67158 95951 64461 65764 66929 65327 65615 66251 66327 66826 95602 95639 95807 64497 66146 95100 98413 98422 67086 66600 66127 64067 66182 67205 67333 96784 66649 64428 95494 66605 95524 65355 66635 95299 67331 66225 65578 66447 66842 65039 64037 64111 95302 65314 96401 66916 95584 64371 95085 95151 66188 66355 59830 66024 59810 64022 66476 64138 95578 96777 95191 66467 64498 98417 64046 64860 64763 64342 95190 95423 64372 66998 67051 95362 67074 65788 64420 65246 65264 66150 96647 66933 96472 64235 65712 96550 66461 66604 66411 66441 67290 95196 64179 65515 66498 96380 95314 64178 66688 59808 66164 64172 66433 66141 64074 66572 66944 65769 95609 67233 96020 64253 65015 65304 66768 95800 96424 64790 64482 64170 66405 95742 64825 96413 65075 96015 65671 67237 65289 59825 67310 64418 64066 65437 66222 65263 66406 66574 96529 95856 96544 65713 64270 96807 66700 65926 66503 98404 65614 59812 66791 64909 65014 65110 65856 95209 96471 65620 64429 65087 65197 64764 64570 64467…
FDA’s list runs to 8,325 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.
Distributed in all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico.
The states and territories these words name
- District of Columbia
- Guam
- Puerto Rico
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?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 8, 2017.
- FDA classified it on May 15, 2018.
- FDA’s Enforcement Report published it on May 23, 2018.
- FDA terminated it on May 18, 2023.
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: E-Mail.
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 8,325 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
-
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.