ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35)
Medical device recall Z-1667-2014. Published in FDA’s Enforcement Report on Jun 4, 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 Jun 4, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 30 states named in where it went
- 257 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?
Software issues with ACUSON SC2000 ultrasound with software version 3/5 (VA35) - may incorrectly display the color flow data in the wrong position and when Doppler Frequency is adjusted, the system does not restart the pulsed wave Doppler or continuous wave Doppler waveform.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system.
257 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model number 10433816; Serial numbers: US: 400290 400425 400439 400441 400443 400447 401176 401591 400763 400787 400789 400790 400791 400792 400794 400797 400063 400860 400868 400872 400873 400877 401041 401187 401441 401540 401590 401602…
Every code shown here, 1,848 characters
Model number 10433816; Serial numbers: US: 400290 400425 400439 400441 400443 400447 401176 401591 400763 400787 400789 400790 400791 400792 400794 400797 400063 400860 400868 400872 400873 400877 401041 401187 401441 401540 401590 401602 401662 401696 401638 401641 400174 400882 401612 401501 401507 401561 401378 400297 401423 401429 401550 401491 401494 401562 401572 401584 401621 400803 400821 400570 401010 401020 401235 401252 401564 401611 400998 400999 401601 401648 400979 401625 401631 400234 400312 400972 401433 400336 401645 400108 400177 400203 400313 400650 400663 400664 400176 400712 400716 401565 400128 400142 400782 400887 400889 401043 401554 400067 401257 401320 401559 401576 401633 401583 400875 400912 400925 400474 400902 401387 401476 401477 401547 401496 401567 401569 401570 401597 401607 401608 401618 401669 400630 401558 401587 401644 400227 400473 400577 400649 401294 401600 401596 ROW: 400652 400733 400737 400746 401437 401443 401478 401495 401188 401191 401650 400546 400945 401506 401371 401325 401393 401403 401543 401571 401580 401581 401613 401620 401623 400302 400348 400347 400553 400558 400726 400995 400996 401120 401123 401209 401260 401288 401338 401344 401442 401452 401551 401555 401556 401522 401560 401577 401579 401588 401589 401603 401604 401606 401643 401699 401630 401676 400125 400200 401434 401658 401661 401626 401435 401498 401217 401389 401431 401563 401585 401605 401687 400155 400180 400307 400704 401428 401451 401541 401521 401582 401594 401595 401624 401632 401637 401640 401666 401688 401689 401695 401004 401508 401546 401519 401627 400247 400263 400511 401045 400497 401664 400284 400252 401566 401502 400655 400214 401394 401367 401617 401634 401651 401652 401657 401659 401663 401665 401681 401685 401686 401694 401698 400253 400836 400840 401118 400218 400990 401127 40118. 0
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 the states of AL, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, KS, LS, MD, MI, MN, MO, NH, NY, NC, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA and WI., and the countries of Australia, Austria, Dominican Rep, France, Germany, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Mexico, New Zealand, Norway, Philippines, Poland, Portugal, Republic Korea, Romania, Russian Fed, Saudi Arabia, Sweden, Switzerland, Turkey, U.A.E. and United Kingdom.
The states and territories these words name
30 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Idaho
- Illinois
- Indiana
- Kansas
- Maryland
- Michigan
- Minnesota
- Missouri
- North Carolina
- New Hampshire
- New York
- Ohio
- Oregon
- Pennsylvania
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
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 Apr 23, 2014.
- FDA classified it on May 28, 2014.
- FDA’s Enforcement Report published it on Jun 4, 2014.
- FDA terminated it on Nov 12, 2015.
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.”
- 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.