SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up…
Medical device recall Z-0962-2022. Published in FDA’s Enforcement Report on Apr 27, 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 Apr 27, 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
- 547 units US 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 error may result in sporadic problems causing scanning workflow interruptions, unexpected user notifications and image artifacts. Sporadic software errors may also occur during interventional workflows. Results in potential patient issues: Possible rescan , Unexpected X-Ray dose and additional contrast media, Delay in diagnosis, scan abort,and patient rescan
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system
547 units US, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Software syngo CT VA30A_SP4 Serial numbers: 106115 106133 106237 106260 106360 106400 106459 106464 106484 106526 106527 106545 106562 108054 108056 108062 108076 108080 108085 108088 108095 108099 108101 108106 108108 108109 108111 108112…
Every code shown here, 1,997 characters
Software syngo CT VA30A_SP4 Serial numbers: 106115 106133 106237 106260 106360 106400 106459 106464 106484 106526 106527 106545 106562 108054 108056 108062 108076 108080 108085 108088 108095 108099 108101 108106 108108 108109 108111 108112 108113 108114 108116 108117 108118 108120 108125 108126 108128 108133 108146 108154 108158 108163 108168 108170 108174 108175 108176 108177 108178 108183 111219 111230 111232 111233 111236 111237 111249 111250 111266 111271 111273 111277 111281 111286 111289 111293 111297 111299 111302 111306 111308 111310 111313 111315 111317 111319 111323 111328 111339 111341 111345 111350 111351 111352 111355 111366 111367 111368 111369 111370 111371 111373 111378 111379 111381 111383 111386 111391 111394 111397 111398 111409 111413 111415 111416 111417 111420 111421 111426 111427 111428 111437 111438 111440 111441 111445 111446 111450 111452 111453 111454 111458 111460 111463 111465 111466 111469 111477 111485 111490 111491 111503 111504 111507 111510 111511 111514 111515 111523 111525 111532 111539 111542 111546 111550 111560 111562 111564 111578 111580 111582 111586 111587 111590 111617 111634 111644 111653 111703 111712 111717 111718 111726 111754 111757 111770 111773 111780 111794 111805 111814 111815 111824 111837 111862 111901 111904 111907 111927 111940 111965 111973 111974 111980 111981 111985 111986 111989 112000 112008 112013 112023 112030 112031 112035 112040 112045 112057 112059 112060 112061 112070 112071 112074 112077 112086 112088 112101 112103 112105 112112 112118 112139 112140 112149 112156 112157 112159 112166 112173 112179 112180 112182 112190 112518 112519 112541 112542 112545 112551 112552 112555 112573 112574 112577 112578 112579 112588 112591 112598 112610 112614 112632 112682 112705 112744 112765 112773 112779 112786 112861 117479 117482 117483 117484 117492 117495 117505 117508 117510 117515 117516 117520 117521 117522 117523 117529 117547 117557 117558 117560 117567 117570 117577 117582 117583 117586 117592 117600…
FDA’s list runs to 4,193 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?
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 Mar 7, 2022.
- FDA classified it on Apr 20, 2022.
- FDA’s Enforcement Report published it on Apr 27, 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: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
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 4,193 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.