ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B
Medical device recall Z-1962-2014. Published in FDA’s Enforcement Report on Jul 9, 2014.
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 Jul 9, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 5 states named in where it went
- 790 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?
There is a potential measurement error with the Auto-Stats (auto statistics) measurement tool on the ACUSON S Family ultrasound system.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.
790 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
10041461, 10440017 - S2000 system 10441730 - S3000 system 10441701 -S1000 system US Serial numbers: 206555 208590 208609 210104 210121 210187 210103 201296 201355 202477 206011 208663 210186 210172 210173 210178 210188 210257 200379 201754…
Every code shown here, 1,997 characters
10041461, 10440017 - S2000 system 10441730 - S3000 system 10441701 -S1000 system US Serial numbers: 206555 208590 208609 210104 210121 210187 210103 201296 201355 202477 206011 208663 210186 210172 210173 210178 210188 210257 200379 201754 202985 206249 206592 206715 206746 207626 207735 207737 207755 207940 207944 208654 208668 208718 208772 208775 208790 208903 208912 208913 210112 210229 210260 201382 206829 208902 208908 202372 202373 210119 210677 202063 203127 206492 207586 207613 208637 208701 208867 210361 201186 208554 210018 210039 210058 210227 201216 201186 208142 208153 210128 210179 210181 210183 210185 210191 210258 210268 210334 210451 208606 210149 210212 210236 210357 200128 210536 210565 210189 210170 202133 210166 210171 210310 210352 210485 210552 210559 200620 203593 200360 203253 203552 207041 210159 208733 210235 210242 210124 210474 210299 210329 208029 208047 208082 208527 207324 210285 208610 208807 208843 210233 210234 210246 206629 210157 205322 206538 208052 208825 208834 208838 202862 208752 210010 210176 210264 210269 210277 210304 210312 210414 210479 210487 207616 207648 207649 208010 208159 210385 201141 201210 203247 208984 210337 210348 210355 210495 210539 203414 210062 201430 210035 200113 207270 207276 207279 210034 210118 210184 210205 210298 210301 210311 210319 201350 205489 206529 208919 208920 210096 210195 207522 207647 210371 210254 210263 207272 207280 207287 207294 210470 200327 210308 210531 201125 208941 200319 202832 207609 210665 210679 207258 207296 207435 207467 207749 207952 210163 210164 210321 210383 210392 210433 210439 210664 207348 208603 210036 210152 210270 210326 210347 210397 207600 207697 207699 210134 210135 210255 210402 207674 201433 205152 207658 208072 208905 210046 210053 210055 210061 210063 210143 210153 210199 210204 210209 210215 210240 210241 210265 210274 210295 210324 210343 210667 201351 201354 202978 210026 210248 210300 208330 208376 210032 210038 210042 210044 210162 210203 210207…
FDA’s list runs to 5,650 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.
Worldwide Distribution - USA including CA, MO, VA, PA, WV, and Internationally to Angola, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt, France, Germany, Greece, India, Iraq, Israel, Italy, Japan, Kazakhstan, Malaysia, Mexico, Morocco, Netherlands, Norway, P.R. China, Philippines, Poland, Portugal, Republic Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., Ukraine, United Kingdom.
The states and territories these words name
- California
- Missouri
- Pennsylvania
- Virginia
- West Virginia
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 3, 2014.
- FDA classified it on Jul 1, 2014.
- FDA’s Enforcement Report published it on Jul 9, 2014.
- FDA terminated it on May 25, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Siemens Medical Solutions USA, Inc., of Mountain View, CA.
- 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 5,650 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.