ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B
Medical device recall Z-1584-2015. Published in FDA’s Enforcement Report on May 13, 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 May 13, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Puerto Rico the one state its words name
- 476 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?
In certain situations, loss of post exercise images can occur in Stress Echo.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. 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.
476, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 400935 400140 400532 400580 400582 400592 400597 400635 400643 400652 400685 400686 400733 400737 400746 400752 400753 400771 400777 400784 400833 400919 400499 400896 400809 400296 400111 400319 400793 400699 400849 400816…
Every code shown here, 1,457 characters
Serial Numbers: 400935 400140 400532 400580 400582 400592 400597 400635 400643 400652 400685 400686 400733 400737 400746 400752 400753 400771 400777 400784 400833 400919 400499 400896 400809 400296 400111 400319 400793 400699 400849 400816 400213 400212 400215 400251 400254 400407 400560 400670 400713 400722 400729 400730 400731 400734 400764 400766 400815 400920 400945 400149 400289 400341 400444 400510 400547 400562 400575 400732 400779 400904 400936 400939 400980 400987 401009 400321 400549 400922 400125 400199 400200 400043 400755 400808 400926 400426 400756 400806 400950 400424 400566 400711 400727 400801 400834 400911 400927 400933 400827 400127 400637 400642 400205 400880 400690 400745 400778 400802 400240 400591 400432 400780 400785 400819 400824 400825 400826 400838 400842 400844 400845 400863 400869 400871 400910 400937 400938 400724 400846 400973 400219 400300 400158 400159 400172 400181 400182 400187 400191 400192 400211 400249 400250 400279 400298 400301 400339 400512 400544 400579 400588 400590 400688 400738 400739 400741 400798 400812 400761 400837 400841 400850 400655 400839 400870 400879 400917 400578 400278 400423 400563 400606 400769 400901 400116 400165 400178 400214 400262 400266 400274 400275 400271 400414 400420 400430 400616 400760 400823 400876 400915 400928 400934 400253 400403 400412 400498 400581 400728 400765 400189 400897 400924 400908 400796 400836 400840 400946 400948 400957 400963 400218 400277 400856
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, Australia, Austria, Bangladesh, Bulgaria, Canada, Colombia, Denmark, Ecuador, Egypt, France, Germany, Hungary, Iceland, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mauritius, Mexico, Netherlands, P.R. China, Philippines, Portugal, Rep. of Yemen, Republic Korea, Russian Fed., San Marino, Saudi Arabia, Singapore, Spain, Suriname, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., United Kingdom, and Venezuela.
The states and territories these words name
- 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 Jul 11, 2012.
- FDA classified it on May 5, 2015.
- FDA’s Enforcement Report published it on May 13, 2015.
- FDA terminated it on May 6, 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.