Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM…
Medical device recall Z-3025-2020. Published in FDA’s Enforcement Report on Oct 7, 2020.
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 Oct 7, 2020. 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
- 767 distributed 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?
Sporadic problems with the current software may result in scanning workflow interruptions and unexpected user notifications causing delay in diagnosis or patient rescan
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #10430603) SOMATOM Drive (Model #10431700) SOMATOM Confidence (Model #10590100) SOMATOM Edge Plus (Model #10267000)
767 distributed in U.S., in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Software versions syngo CT VB20 and syngo CT VB20_SP1 Serial Numbers: 59812 59819 59820 59823 59825 59828 64036 64051 64064 64066 64104 64132 64148 64160 64211 64218 64221 64347 64407 64427 64498 64500 64501 64516 64519 64605 64677 64707…
Every code shown here, 1,996 characters
Software versions syngo CT VB20 and syngo CT VB20_SP1 Serial Numbers: 59812 59819 59820 59823 59825 59828 64036 64051 64064 64066 64104 64132 64148 64160 64211 64218 64221 64347 64407 64427 64498 64500 64501 64516 64519 64605 64677 64707 64712 64732 64785 64869 64924 64999 65022 65157 65159 65186 65229 65235 65238 65247 65251 65297 65299 65370 65371 65382 65443 65478 65493 65501 65515 65556 65586 65607 65611 65652 65667 65728 65768 65770 65773 65777 65793 65795 65803 65804 65805 65808 65854 65909 65926 65956 66021 66032 66062 66095 66116 66126 66150 66151 66164 66183 66188 66197 66219 66223 66225 66232 66234 66237 66248 66265 66280 66290 66308 66319 66335 66396 66403 66407 66470 66490 66498 66502 66503 66579 66612 66635 66649 66664 66677 66688 66844 66850 66859 66882 66925 66933 66969 66999 67048 67122 67133 67192 67218 67229 67232 67236 67297 67326 67363 67380 73008 73013 73051 73054 73059 73066 73090 73126 73152 73262 73296 73320 73409 73413 73423 73424 73430 73471 73490 73493 73497 73513 73520 73531 73591 73636 73673 73786 73873 73895 73931 73935 73937 73938 74068 74093 74098 74117 74118 74128 74153 74156 74158 74191 74207 74251 74511 74922 74924 74927 75437 75450 75454 75475 75476 75487 75500 75501 75510 75512 75524 75527 75532 75535 75540 75550 75555 75567 75570 75571 75576 75588 75600 75602 75604 75605 75616 75617 75708 75711 75714 75716 75728 75743 75750 75754 75755 75760 75765 75769 75770 75775 75778 75787 75788 75789 75790 75793 75794 75804 75805 75806 75808 75818 75820 75823 75824 75837 75843 75848 75849 75850 75852 75867 75877 75884 75885 75888 75893 75900 75905 75906 75913 75916 75919 75923 75931 75939 75941 75942 75944 75949 75953 75959 75964 75971 75973 75974 75976 75980 75981 75983 75984 75993 75994 75999 76000 76001 76003 76006 76008 76010 76016 76019 76027 76041 76046 76050 76056 76057 76059 76061 76064 76073 76074 76080 76089 76090 76091 76097 76101 76114 76118 76135 76136 76138 76140 76142 76147 76152 76156 76162 76163 76166 76168 76169 76170…
FDA’s list runs to 4,696 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.
Nationwide
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 Jun 22, 2020.
- FDA classified it on Sep 28, 2020.
- FDA’s Enforcement Report published it on Oct 7, 2020.
- FDA terminated it on Mar 9, 2021.
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 4,696 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.