ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1
Medical device recall Z-2314-2015. Published in FDA’s Enforcement Report on Aug 5, 2015.
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 Aug 5, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 1789 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?
Potential measurement error on ACUSON S Family ultrasound system when using the Doppler manual trace measurement tool in full screen format that has a low probability of misdiagnosis.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
1789 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model numbers: 10041461, 10440017 S2000 system 10441730 S3000 system 10441701 S1000 system; software version VC30A, VC30B, VC30C, or VC31A; Serial numbers US: 210104 210121 210187 211161 210103 206479 206595 206701 206726 200313…
Every code shown here, 1,999 characters
Model numbers: 10041461, 10440017 S2000 system 10441730 S3000 system 10441701 S1000 system; software version VC30A, VC30B, VC30C, or VC31A; Serial numbers US: 210104 210121 210187 211161 210103 206479 206595 206701 206726 200313 200394 207073 207099 210186 210811 211030 211147 211148 211477 212130 210509 210510 210540 210702 210714 210911 210957 211031 211097 211259 211368 211441 211444 211454 211511 211612 211689 211694 210172 210173 210178 210188 210257 211439 211071 211438 211453 211459 200245 201227 201256 201387 201389 206039 208718 208772 210112 210229 210260 210689 210798 210821 210903 211270 211577 211645 211660 210607 210622 210653 210662 210703 210729 210742 210744 210747 210753 210788 210795 210924 210930 210931 210934 210947 211047 211067 211121 211549 211581 211641 210119 210677 211483 211289 211300 210226 208637 211364 211385 211710 212156 212157 212167 200624 202323 202555 202937 210018 210039 210054 210055 210058 210061 210227 210423 210426 210427 210629 211515 212227 206790 206049 206238 207997 208120 208142 210032 210038 210128 210179 210181 210183 210185 210191 210207 210258 210268 210334 210361 210451 211742 205174 210149 210212 210236 210357 210820 211334 212132 210248 210520 210536 210565 210673 210856 210999 211104 211120 211126 211208 211209 210189 211156 211165 211215 205415 210166 210171 210174 210310 210352 210485 210552 210559 210669 210779 210832 211180 211183 211361 212137 202064 205970 208220 210666 211158 211325 211335 211336 211337 211338 211340 211347 211352 211355 211357 211362 207041 208626 210053 210153 210159 211039 211079 211081 211425 211611 212064 201219 211747 210235 210242 210170 211512 210124 210474 210489 210571 210745 210888 210299 210329 210740 210756 211091 211465 211579 211614 210139 210343 203158 203237 210157 211008 211278 210692 210748 210777 211421 207048 207087 207095 207096 211024 210285 210233 210234 210246 210010 210176 210264 210269 210277 210304 210312 210414 210479 210487 210650 210652 211550 211551…
FDA’s list runs to 12,709 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 - Nationwide Distribution including Puerto Rico and to the countries of : Algeria, Angola, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia Herzeg., Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cyprus, Czech Republic, Dem. Rep. Congo, Denmark, Dominican Rep., Ecuador, Egypt, El Salvador, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Malaysia, Mexico, Morocco, Nepal, Netherlands, New Zealand, Norway, P.R. China, Peru, Philippines, Poland, Portugal, Republic Korea, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad,Tobago, Turkey, Turkmenistan, U.A.E., Ukraine, United Kingdom, Uzbekistan, Venezuela and Vietnam.
The states and territories these words name
- Puerto Rico
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.
The words say it went outside the United States too.
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 25, 2015.
- FDA classified it on Jul 29, 2015.
- FDA’s Enforcement Report published it on Aug 5, 2015.
- FDA terminated it on Oct 19, 2017.
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 12,709 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.