18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C
Medical device recall Z-1875-2017. Published in FDA’s Enforcement Report on May 3, 2017.
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 3, 2017. 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
- 2,045 systems 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?
When scanning with the 18L6 HD transducer on the ACUSON HELX” Evolution with Touch Control, the ultrasound system may display a triple image or an image with a dark band. For the triple image issue, the system repeats one-third of the aperture, but does not display the full field of view.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 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.
2,045 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
US serial numbers: 200113 200245 200394 200695 200706 200715 200935 201159 201256 201916 202076 202551 202559 202584 202587 202600 202626 202937 203212 205736 205850 206286 206919 206949 207048 207073 207087 207096 207099 207551 207552…
Every code shown here, 2,000 characters
US serial numbers: 200113 200245 200394 200695 200706 200715 200935 201159 201256 201916 202076 202551 202559 202584 202587 202600 202626 202937 203212 205736 205850 206286 206919 206949 207048 207073 207087 207096 207099 207551 207552 207560 207566 207572 207648 207713 208114 208142 208153 208984 209481 210012 210017 210061 210128 210143 210157 210163 210173 210188 210241 210274 210324 210334 210439 210508 210569 210584 210664 210665 210666 210679 210703 210735 210737 210742 210744 210747 210753 210811 210832 210861 210873 210979 210981 211018 211026 211070 211093 211124 211138 211158 211167 211244 211249 211302 211316 211325 211335 211336 211337 211338 211340 211347 211352 211354 211355 211357 211362 211375 211460 211480 211499 211513 211549 211581 211626 211627 211637 211639 211643 211647 211648 211649 211650 211653 211659 211666 211715 211717 211720 211723 211732 211733 211745 211750 211751 211752 211767 211769 211770 211778 211782 211788 212069 212070 212082 212083 212084 212092 212093 212094 212209 212210 212211 212212 212215 212216 212217 212218 212219 212220 212242 212243 212244 212245 212246 212247 212248 212249 212250 212251 212253 212254 212255 212257 212296 212298 212299 212308 212309 212311 212321 212334 212343 212344 212345 212346 212364 212385 212416 212417 212427 212457 212479 212492 212497 212541 212542 212543 212544 212545 212546 212547 212548 212550 212551 212552 212554 212582 212584 212585 212586 212588 212589 212591 212592 212597 212599 212601 212602 212603 212604 212605 212607 212612 212613 212614 212615 212617 212618 212619 212622 212623 212624 212630 212632 212635 212640 212641 212642 212644 212645 212646 212647 212649 212650 212654 212664 212665 212666 212668 212672 212673 212674 212675 212676 212678 212679 212681 212682 212683 212685 212686 212687 212691 212697 212698 212702 212704 212705 212706 212715 212716 212721 212722 212723 212725 212730 212732 212736 212740 212741 212746 212750 212751 212754 212755 212756 212758 212762 212764 212766…
FDA’s list runs to 14,356 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 - USA (nationwide) Distribution and to the countries of : United Arab Emirates, Argentina, Armenia, Austria, Australia, Azerbaijan, Bahrain,Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, Columbia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, El Salvador, Ethiopia, Egypt, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, Venezuela, Vietnam and 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 Mar 30, 2017.
- FDA classified it on Apr 24, 2017.
- FDA’s Enforcement Report published it on May 3, 2017.
- FDA terminated it on Mar 21, 2019.
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 14,356 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.