Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz ***
Medical device recall Z-1330-2021. Published in FDA’s Enforcement Report on Apr 7, 2021.
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 Apr 7, 2021. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- 44 states named in where it went
- 1,172 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 ultrasound system averages the Mean Sac Diameter (MSD) and Gestational Sac Diameter (GSD) into the Estimated Date of Delivery (EDD) calculation. This may result in an incorrect EDD, which may influence patient management decisions regarding induction of labor and elective caesarean delivery, which may result in premature births.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
1,172 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model: 11148775 Equipment Serial Numbers (U.S.) 800015 800101 800103 800104 800105 800106 800107 800108 800109 800111 800112 800113 800116 800118 800119 800121 800134 800138 800139 800141 800142 800143 800149 800150 800151 800152 800153…
Every code shown here, 1,994 characters
Model: 11148775 Equipment Serial Numbers (U.S.) 800015 800101 800103 800104 800105 800106 800107 800108 800109 800111 800112 800113 800116 800118 800119 800121 800134 800138 800139 800141 800142 800143 800149 800150 800151 800152 800153 800155 800157 800158 800161 800165 800168 800172 800174 800175 800176 800177 800178 800182 800183 800184 800185 800186 800189 800190 800191 800192 800193 800194 800195 800196 800198 800199 800201 800203 800204 800205 800208 800209 800210 800211 800215 800217 800220 800221 800223 800225 800226 800227 800228 800229 800232 800233 800234 800235 800237 800239 800241 800242 800243 800244 800247 800249 800251 800254 800256 800257 800258 800259 800260 800263 800265 800267 800268 800270 800273 800274 800278 800280 800281 800285 800286 800291 800292 800293 800295 800300 800301 800302 800303 800304 800305 800308 800313 800314 800317 800319 800320 800321 800324 800328 800333 800335 800336 800339 800341 800342 800348 800349 800355 800360 800361 800363 800366 800369 800370 800375 800376 800383 800390 800393 800397 800405 800408 800411 800418 800424 800427 800428 800429 800433 800435 800436 800440 800451 800462 800463 800464 800466 800467 800469 800473 800474 800475 800480 800481 800486 800489 800490 800495 800498 800505 800506 800509 800511 800515 800516 800518 800521 800523 800525 800528 800532 800535 800540 800546 800549 800550 800552 800555 800556 800559 800560 800564 800566 800567 800579 800581 800583 800590 800592 800594 800597 800598 800607 800609 800611 800618 800623 800627 800628 800630 800631 800634 800638 800639 800640 800645 800648 800650 800651 800652 800653 800657 800661 800662 800667 800668 800671 800672 800673 800674 800675 800677 800680 800683 800686 800688 800693 800694 800696 800701 800703 800707 800708 800735 800738 800739 800741 800742 800743 800745 800747 800749 800752 800754 800756 800758 800760 800761 800762 800763 800771 800775 800786 800787 800788 800789 800791 800800 800805 800806 800807 800809 800813 800821 800834…
FDA’s list runs to 8,286 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.
U.S.: AK, AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY O.U.S.: U.A.E., Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Israel, Italy, Japan, Kazakhstan, Kuwait, Mexico, Morocco, Netherlands, New Zealand, Oman, Philippines, Poland, Portugal, Qatar, Republic Korea, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, and Vietnam
The states and territories these words name
44 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Mississippi
- North Carolina
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
- Wyoming
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Feb 4, 2021.
- FDA classified it on Apr 1, 2021.
- FDA’s Enforcement Report published it on Apr 7, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Siemens Medical Solutions USA, Inc., of Issaquah, WA.
- 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 8,286 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.