ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imaging system is intended for the…
Medical device recall Z-1065-2018. Published in FDA’s Enforcement Report on Mar 21, 2018.
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 Mar 21, 2018. 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
- 564 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?
The application may underestimate the EROA (Effective Regurgitant Orifice Area) in comparison to the same patient results obtained with the 4Z1c volume transthoracic echocardiography transducer.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
ACUSON SC2000 Ultrasound System Product Usage: 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. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
564 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Software versions VB10A, VB10B, VB10D, VB10E that have PRIME license 11146943 and eSie PISA license 10439823. Serial numbers involved are: 400154 400173 400201 400252 400278 400294 400355 400423 400497 400518 400606 400614 400655 400761…
Every code shown here, 1,994 characters
Software versions VB10A, VB10B, VB10D, VB10E that have PRIME license 11146943 and eSie PISA license 10439823. Serial numbers involved are: 400154 400173 400201 400252 400278 400294 400355 400423 400497 400518 400606 400614 400655 400761 400836 400840 400888 400899 400909 401173 401186 401195 401207 401230 401246 401254 401259 401289 401361 401367 401377 401423 401429 401443 401444 401451 401452 401454 401455 401491 401494 401501 401546 401561 401565 401567 401569 401572 401577 401580 401589 401603 401604 401606 401607 401612 401627 401643 401649 401654 401658 401661 401697 401699 401704 401711 401724 401731 401751 401757 401761 401762 401770 401775 401776 401784 401794 401807 401812 401815 401819 401823 401836 401844 401869 401876 401886 401887 401908 401910 401911 401921 401924 401962 401970 401993 402015 402018 402056 402061 402066 402067 402069 402071 402073 402075 402079 402088 402090 402091 402092 402116 402119 402122 402136 402138 402139 402140 402141 402144 402145 402161 402168 402172 402173 402176 402177 402188 402189 402194 402197 402200 402203 402210 402213 402214 402215 402216 402218 402219 402225 402226 402236 402242 402259 402267 402268 402270 402271 402272 402273 402274 402275 402277 402278 402290 402295 402296 402299 402300 402301 402302 402303 402304 402307 402309 402313 402316 402318 402326 402327 402328 402332 402333 402337 402339 402340 402343 402344 402347 402348 402349 402350 402352 402354 402355 402369 402370 402371 402374 402377 402381 402383 402384 402385 402389 402392 402393 402400 402405 402410 402411 402412 402414 402416 402421 402423 402424 402428 402429 402432 402433 402435 402437 402438 402440 402450 402452 402456 402459 402465 402467 402469 402472 402481 402485 402492 402503 402504 402505 402508 402516 402520 402526 402529 402535 402539 402544 402545 402552 402553 402555 402558 402562 402565 402567 402568 402569 402575 402577 402579 402580 402582 402583 402584 402585 402589 402590 402592 402595 402599 402602 402606 402617 402618…
FDA’s list runs to 4,090 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 - U.S. nationwide and the countries of Algeria, Argentina, Australia, Austria, Azerbaijan, Brazil, Brunei, Canada, Chile, China, Columbia, Ecuador, Egypt, El Salvador, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Malaysia, Malta, Mexico, Netherlands, Norway, Pakistan, Philippines, Poland, Portugal, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, U.A.E, Ukraine, United Kingdom, United States, Uzbekistan, and Vietnam.
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 Jan 26, 2018.
- FDA classified it on Mar 15, 2018.
- FDA’s Enforcement Report published it on Mar 21, 2018.
- FDA terminated it on Jul 2, 2020.
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 4,090 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.