ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option
Medical device recall Z-1959-2015. Published in FDA’s Enforcement Report on Jul 8, 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 Jul 8, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 573 devices 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?
When performing a 2D Stress Echo study, some following keystrokes result in a potential loss of data, where some selected clips may not be saved as part of the study.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. Model number 10433816: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
573 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model number 10433816 between software version VA16A and VA30A: US Serial numbers: 400930 401216 401375 401343 401049 400538 401115 400572 400464 401346 400196 401030 401246 400222 400455 400457 401090 401078 400318 401345 400668 400667…
Every code shown here, 1,994 characters
Model number 10433816 between software version VA16A and VA30A: US Serial numbers: 400930 401216 401375 401343 401049 400538 401115 400572 400464 401346 400196 401030 401246 400222 400455 400457 401090 401078 400318 401345 400668 400667 401158 400545 401022 401184 401308 401141 401311 400462 400467 400460 400461 401383 400466 401149 401300 400479 400493 400519 400861 400117 401070 400907 400740 400552 400454 401204 400530 400814 400818 400835 400900 400810 400811 401155 401156 400736 401279 401280 400220 400221 400742 400913 401351 400069 400326 400123 400137 400197 400234 400152 401322 401323 401327 400967 400974 400884 400795 401265 401266 401258 400848 400874 400883 400175 401348 400759 400226 400885 400757 400472 400536 401278 400236 400629 400640 401384 400800 400768 400775 400679 400680 400269 400483 400484 401234 401256 401003 401013 401014 400886 400890 400898 400794 400797 400978 401023 401025 400940 400954 400955 400992 400153 400554 401061 401328 400914 400715 400065 401169 401174 400770 401533 400958 401271 401286 401237 400475 401187 400970 400693 400589 401305 401075 401031 400291 400676 400678 400665 400683 401257. ROW serial numbers: 400935 400604 400682 400597 400833 400140 400753 401016 400166 400582 400983 401036 400784 400919 401376 401159 400186 400499 400896 400809 401160 400774 400282 400758 400723 401532 400402 400633 400296 400111 400319 400515 400942 400793 400343 400849 401400 400816 401143 400216 400212 400713 400215 400730 400734 401021 400920 401140 401239 401128 401052 400815 400766 401133 401018 400729 400731 400213 400903 401334 401048 401056 400722 401273 401225 401210 400904 401229 400980 400961 400941 400325 400562 400242 400444 400149 400547 400939 400510 401050 401142 400779 400341 400289 400987 401009 400321 400549 401077 400922 400702 400043 401329 401253 401295 400755 400808 400926 400150 401119 400806 400426 400428 400429 400756 401312 401192 401126 400711 401293 400566 400977 401079 400551 401219 400696 400834 400500…
FDA’s list runs to 4,115 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 - US Distribution and to the countries of : Albania, Angola, Armenia, Australia, Austria, Bangladesh, Belarus, Bolivia, Bosnia Herzog, Brazil, Brunei, Bulgaria, Canada, Colombia, Czech Republic, Ecuador, Egypt, Finland, France, Germany, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Kuwait, Lithuania, Malaysia, Maldives, Mauritius, Mexico, Netherlands, Nigeria, Oman, P.R. China, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Russian Fed, San Marino, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Suriname, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., United Kingdom and Venezuela
These words name no state.
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 May 29, 2015.
- FDA classified it on Jul 2, 2015.
- FDA’s Enforcement Report published it on Jul 8, 2015.
- FDA terminated it on Mar 9, 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 4,115 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.