SOMATOM Definition AS, Computed tomography system Product Usage: SOMATOM Definition Flash systems are…
Medical device recall Z-0604-2017. Published in FDA’s Enforcement Report on Nov 23, 2016.
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 Nov 23, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 762 systems distrtibuted in U.S. 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?
A problem can occur with the small light marker windows, used for the positioning laser and are integrated in the front cover of the SOMATOM Definition AS and Definition Flash systems, by either becoming loose or potentially dropping out. There is a risk that a person could touch rotating or electrical parts of the gantry if they were to reach through the window opening.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
SOMATOM Definition AS, Computed tomography system Product Usage: SOMATOM Definition Flash systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
762 systems distrtibuted in U.S., in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 73064 64789 64492 65127 64464 64471 65380 66632 65852 64668 64239 65364 64580 73476 73339 64278 64756 73059 64800 64412 65288 64645 64725 73421 64508 65339 65346 64714 65831 64123 64246 65690 65752 64658 73312 66858 65491…
Every code shown here, 1,996 characters
Serial Numbers: 73064 64789 64492 65127 64464 64471 65380 66632 65852 64668 64239 65364 64580 73476 73339 64278 64756 73059 64800 64412 65288 64645 64725 73421 64508 65339 65346 64714 65831 64123 64246 65690 65752 64658 73312 66858 65491 66611 64465 65076 64454 65762 64485 64446 64673 66319 64419 66518 65968 66506 66171 66243 73544 64368 64736 65620 64081 64117 64549 65175 65569 64112 66287 66292 64164 64180 66087 65322 65768 65425 65810 73343 73374 65326 64461 65764 66929 65615 66251 66327 66826 64497 66146 64067 64428 65355 66635 66225 65039 64111 65314 64371 66188 66355 66476 64138 73518 65209 66467 64860 66649 66182 73258 64342 73579 64372 66998 66759 64420 65264 66150 64235 65712 66461 66604 73120 66411 64179 65515 66498 73108 64178 66688 66164 64172 66433 66141 64074 66572 66944 64253 65015 66768 64482 64170 66405 64825 64328 65075 65671 64418 65437 66222 65263 66406 66574 65713 64270 66700 65926 73427 66475 65614 73187 65013 66791 64909 65014 65110 65856 64429 65087 65197 64764 64570 64467 64410 73533 64248 64604 66119 66193 64841 64707 64821 73423 73424 73493 73520 66233 65804 66085 73459 64290 64274 65306 66790 64337 65554 73303 65960 64734 65036 73240 73279 73278 64575 64289 64724 65311 65366 65407 64623 66451 64685 73224 66928 65403 64079 64823 64905 66690 64807 64770 66964 65568 66924 64709 64082 65233 66075 66626 66965 66151 66911 64863 65959 66557 65576 66148 66705 65418 66822 73352 64968 64481 65393 65755 66450 65799 65501 66234 65413 66556 73526 65186 65927 65466 65267 64296 64421 64423 66745 64259 65802 73487 73492 73494 73497 64430 73016 73310 65286 65302 66918 64801 64284 66527 64624 66458 64959 66850 73409 64627 64692 64397 64947 64228 66472 64463 65283 66667 64913 65736 64835 64834 65423 65313 66011 65081 65279 64635 66297 64078 66818 65818 64931 64244 65530 65412 65446 66683 66704 66999 66396 64068 64629 66201 65012 73130 66914 66802 66304 66423 66473 64291 73013 73300 73499 73535 73090 73377 64402 65480 65062 66237 66595 64953 64194 73031…
FDA’s list runs to 4,575 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?
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 Oct 19, 2016.
- FDA classified it on Nov 16, 2016.
- FDA’s Enforcement Report published it on Nov 23, 2016.
- FDA terminated it on Mar 13, 2017.
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 4,575 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.