SOMATOM Force with software syngo.CT VB20
Medical device recall Z-0283-2022. Published in FDA’s Enforcement Report on Dec 1, 2021.
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 Dec 1, 2021. 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
- 232 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 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
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
SOMATOM Force with software syngo.CT VB20 Model #10742326
232 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,407 characters
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
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 Aug 30, 2021.
- FDA classified it on Nov 24, 2021.
- FDA’s Enforcement Report published it on Dec 1, 2021.
- FDA terminated it on Jan 16, 2024.
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.”
- 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.