ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option
Medical device recall Z-2321-2015. 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 for where it went
- 629 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 repositioning the Virtual Touch IQ region of interest from the original (default) location, the lateral position of the measurement tool may not align with the lateral position of the shear velocity data.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 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.
629 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; VTIQ Option - 10439521 and 10439522. Serial numbers for US: 210104 211147 211148 210257 211071 201387 201389 206511 206574 206592 206619 206732 206832 208718 208772…
Every code shown here, 1,994 characters
Model numbers: 10041461, 10440017 - S2000 system; 10441730 - S3000 system; VTIQ Option - 10439521 and 10439522. Serial numbers for US: 210104 211147 211148 210257 211071 201387 201389 206511 206574 206592 206619 206732 206832 208718 208772 210931 211483 212156 212157 202555 210055 210061 210423 210426 210427 210629 206049 210032 210128 210334 210361 211742 211334 211156 211165 211215 211180 211183 208220 210666 211158 211338 211425 211611 212064 211091 210343 203158 211278 210692 210748 210777 210010 210479 211550 211551 205213 211123 211448 211709 210993 210164 210839 210954 210961 210672 200113 200140 202137 210034 210215 211777 207390 210505 210521 210861 200695 210759 210761 210764 210768 210769 201673 201979 206346 210265 210488 210573 210631 210667 210783 210825 210843 211124 211167 211174 211260 211316 211319 211320 211499 211513 211627 211635 211636 211637 211639 211643 211647 211649 212070 212133 212135 206901 210044 210169 210203 210213 210217 210506 210517 210708 210853 211168 211221 211273 211291 211295 211322 211401 211405 211467 211538 211558 211653 210278 207050 210844 211151 211092 211648 210035 212235 206969 202197 211217 207411 207438 207715 208219 208482 208645 210276 210674 211218 211267 211305 211321 211449 211620 211654 212131 201279 201281 210842 210855 210992 211066 211088. Serial numbers for ROW: 211768 210671 211803 212186 206153 206181 210340 210752 210763 211060 211182 211351 211705 210494 210935 207083 207298 207553 208176 203090 203106 206480 210105 210725 210799 211059 211262 210064 202134 203148 203282 203549 205242 205260 205381 206678 206756 206819 206857 207988 209048 209088 209120 211085 211397 206341 210085 211432 211445 210144 210225 210620 210793 211178 207878 210218 210707 210718 211041 208127 200974 202859 206917 210475 210691 210106 210073 210267 210280 210281 210288 210303 210306 210377 210400 210438 210490 210514 210749 210851 210860 210901 211095 211117 211624 211662 211775 212065 212162 212239 212287 200323 200734…
FDA’s list runs to 4,563 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 Nationwide and the countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Dominican Rep., France, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kenya, Malaysia, Mexico, Nepal, Netherlands, New Zealand, 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.
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.
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 30, 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 4,563 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.