ACUSON SC2000 ultrasound systems
Medical device recall Z-0182-2016. Published in FDA’s Enforcement Report on Nov 4, 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 Nov 4, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 2 states named in where it went
- 2,099 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?
Siemens will provide all customers a new version of system software (VA35E or VB10C depending on the hardware configuration). Hardware fixes will be implemented to address situations where the metal component used to engage the wheel lock becomes disconnected, and where the system locks up due to misalignment between the bezel and MPI board, in all units that have not already been corrected.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
ACUSON SC2000 ultrasound systems model 10433816 Imaging system that provides the ability to measure anatomical structures and calculation packages that provide info for clinical diagnosis purposes.
2,099 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 400217 400290 400425 400439 400441 400443 400447 401496 401719 402310 402495 400308 400641 400770 401110 401114 401135 401136 401138 401169 401174 401176 401366 401370 401406 401460 401591 401750 401793 401803 402090 402139…
Every code shown here, 1,997 characters
Serial Numbers: 400217 400290 400425 400439 400441 400443 400447 401496 401719 402310 402495 400308 400641 400770 401110 401114 401135 401136 401138 401169 401174 401176 401366 401370 401406 401460 401591 401750 401793 401803 402090 402139 402177 402197 402255 402323 402327 402339 402351 402387 402492 402508 402562 402566 400063 400066 400090 400261 400350 400763 400787 400789 400790 400791 400792 400794 400797 400881 400886 400888 400890 400892 400898 401957 402451 400139 400141 400171 400235 400287 400291 400292 400293 400337 400338 400351 400458 400459 400475 400526 400527 400529 400583 400589 400593 400620 400693 400720 400743 400843 400868 400872 400873 400877 400878 400891 400895 400921 400958 400959 400960 400970 400989 401001 401012 401029 401031 401041 401044 401065 401075 401081 401083 401130 401132 401175 401187 401237 401243 401271 401286 401291 401305 401426 401441 401445 401540 401590 401662 401705 401725 401728 401744 401746 401753 401758 401810 401832 401841 401863 401889 401892 401910 401915 401916 401917 401929 401943 401969 402011 402027 402050 402051 402077 402109 402131 402190 402191 402220 402226 402229 402242 402243 402244 402253 402257 402260 402275 402296 402341 402379 402396 402398 402436 402443 402444 402503 402514 402570 402579 400065 400100 400492 400715 400914 401108 401109 401255 401638 401641 401845 402279 400174 400440 400448 400538 400541 400572 400615 400622 400623 400626 400799 400830 400882 400931 401049 401115 401285 401343 401375 401397 401402 401409 401424 401425 401430 401570 401730 401734 401991 402026 401890 401898 401899 401906 400029 400070 400195 400223 400224 400233 400309 400454 400456 400530 400552 400617 400814 400818 400835 401281 401476 401547 401565 401567 401568 401602 401900 401950 401959 401961 402280 402322 402449 400472 401173 401289 401501 401507 401552 401600 401797 401825 401837 402236 402386 400665 400676 400678 400683 400822 400145 400179 400310 400311 400968 401378 401446 400175 400226 400236 400244…
FDA’s list runs to 14,714 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 and Albania, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia Herzeg., Brazil, Brunei, Bulgaria, Canada, Colombia, Croatia, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt, El Salvador, Finland, France, Georgia, Germany, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Lithuania, Malaysia, Maldives, Malta, Mexico, Netherlands, New Zealand, Nigeria, Norway, P.R. China, Pakistan, Philippines, Poland, Portugal, Republic Korea, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Turkmenistan, U.A.E., Ukraine, United Kingdom, Uzbekistan, Venezuela, and Vietnam.
The states and territories these words name
- Georgia
- Puerto Rico
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 Oct 7, 2015.
- FDA classified it on Oct 28, 2015.
- FDA’s Enforcement Report published it on Nov 4, 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 14,714 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.