ACUSON SC2000 Ultrasound System
Medical device recall Z-0824-2014. Published in FDA’s Enforcement Report on Feb 5, 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 Feb 5, 2014. 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
- 843 active 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?
The user interface assembly on the ACUSON SC2000 may become loose with the potential for the entire module to fall off of the ultrasound system.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
ACUSON SC2000 Ultrasound System; Power Input: 100-240VAC, 1600W Max, 50/60 Hz. Manufacturer: Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 SC2000 ultrasound imaging system is intended for Cardiac, neo-natal and fetal cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal interoperative, Intraoperative Neurological, Musculo-skeletal Conventional and musculo-skeletal Superficial Applications. The system also provided the ability to measure anatomical structures and calculation packages that provide information to the clinician that my be used adjunctively and with other medical data obtained by a physician for clinical diagnosis purposes.
843 active 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 lower than 401100. Serial numbers: 400935 400686 400597 400833 400140 400753 400752 400771 401016 400166 400635 400582 400983 400532 400580 400592 400804 400733 400737 400652 401036 400643 400746…
Every code shown here, 1,998 characters
Model number 10433816; Serial numbers lower than 401100. Serial numbers: 400935 400686 400597 400833 400140 400753 400752 400771 401016 400166 400635 400582 400983 400532 400580 400592 400804 400733 400737 400652 401036 400643 400746 400349 400784 400919 400685 400777 400186 400499 400896 400809 400259 400282 400758 400762 400831 400723 400402 400633 401027 400111 400319 400515 400942 400793 400699 400849 400816 400216 400212 400713 400764 400730 400734 401021 400215 400735 400920 401052 400815 400766 401018 400729 400731 400213 400903 400254 400670 400560 401048 401056 400280 400722 400945 400405 400407 400546 400975 400904 400982 400980 400151 400961 400941 400325 400562 401073 400242 400415 400952 400732 400444 400149 400543 400661 400547 400726 400939 400510 401050 400243 400779 401072 400106 400147 400173 400302 400347 400348 400453 400553 400557 400558 400995 400996 400936 400341 400289 400987 401009 400575 400922 400702 400125 400199 400200 400611 400755 400808 400926 400950 400744 400150 400806 400427 400426 400428 400429 400495 400756 400624 400568 400911 400418 400566 400977 400551 400801 400157 400696 400727 400834 400207 400933 401079 400115 400416 400422 400599 400600 400500 400180 400307 400711 400608 400601 401068 400927 400424 401033 400127 400642 400637 400880 400205 400569 400690 400745 401004 401074 400802 400778 400614 400524 400523 400240 400591 401037 400901 400247 400263 400511 400514 400276 400703 400281 400469 401046 400627 401032 400819 401060 401058 400113 400241 400825 400653 400328 400910 400844 400869 401059 400598 401057 400677 400332 400824 400607 400842 401076 400419 400323 400329 400651 401053 401097 400785 400644 400602 400237 400432 400684 400413 400938 400625 400335 400976 400330 400525 400714 400333 401094 400838 400971 400609 400434 400845 400522 400068 400085 400906 400916 401091 400863 400706 400871 400286 400780 401051 400256 400937 400327 400482 400846 401045 400594 400724 400973 400497 400490 400219 401039 400966 401017…
FDA’s list runs to 5,840 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 Albania, Australia, Austria, Bangladesh, Belgium, Bosnia Herzeg, Brazil, Brunei, Canada, Columbia, Denmark, Ecuador, Egypt, Finland, France, Germany, Iceland, India, Israel, Italy, Japan, Kuwait, Malaysia, Mauritius, Mexico, Netherlands, Norway, Oman, P.R. China, Philippines, Poland, Qatar, Rep of Yemen, Republic Korea, Romania, Russian Fed. San Marino, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E. United Kingdom and Venezuela.
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 Dec 22, 2013.
- FDA classified it on Jan 24, 2014.
- FDA’s Enforcement Report published it on Feb 5, 2014.
- 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.”
- FDA’s list of codes runs to 5,840 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.