Lower risk Medical device recall · FDA · Published February 4, 2021

Siemens ACUSON Sequoia Ultrasound System May Cause Incorrect Delivery Date Calculations

Siemens recalls ACUSON Sequoia ultrasound systems with specific equipment serial numbers due to potential incorrect Estimated Date of Delivery calculations, which could lead to premature births. Affected units include those with serial numbers listed in the recall notice.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1330-2021Medical device Siemens ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmSiemens Medical Solutions USA, Inc.22010 SE 51st St · Issaquah, WA 98029-7298

✎ GovInfoNow plain-language explainer

Siemens is recalling certain ACUSON Sequoia ultrasound systems that may incorrectly calculate the estimated date of delivery (EDD) for pregnancies. This could lead to premature births if healthcare providers rely on the inaccurate date for decisions about labor induction or cesarean sections. Read more at govinfonow.com/recall/63304-siemens-acuson-sequoia-ultrasound-system-may-cause-incorrect-delivery-date.

Source Summary by GovInfoNow · govinfonow.com/recall/63304-siemens-acuson-sequoia-ultrasound-system-may-cause-incorrect-delivery-date · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1330-2021

Cite this page

“Siemens ACUSON Sequoia Ultrasound System May Cause Incorrect Delivery Date Calculations.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63304-siemens-acuson-sequoia-ultrasound-system-may-cause-incorrect-delivery-date. Based on FDA recall #Z-1330-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1330-2021%22&limit=1).

The FDA announced on Feb. 4, 2021, that Siemens Medical Solutions USA, Inc. is recalling ACUSON Sequoia diagnostic ultrasound systems because the software may calculate an incorrect estimated date of delivery. This error could influence patient management decisions regarding labor induction and elective caesarean delivery.

How to tell if you have it

Brand: Siemens
Product: ACUSON Sequoia Diagnostic Ultrasound Systems
Model: 11148775
U.S. Equipment Serial Numbers: 800015 through 802263 (as listed in record)
O.U.S. Equipment Serial Numbers: 800344 through 802273 (as listed in record)

The hazard

The ultrasound system averages the Mean Sac Diameter and Gestational Sac Diameter into the Estimated Date of Delivery 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.

Context

GovInfoNow's records show Siemens Medical Solutions USA, Inc. has 182 other recalls on record since June 6, 2017. Other recent recalls of similar products include the Siemens ARTIS icono Ceiling Monitor Recall for loose screws (June 8, 2026), the Siemens ARTIS icono ceiling recall for risk of loss of movement (May 20, 2026), and the Siemens ARTIS Pheno VE30A/VE40A recall for inaccurate 3D scans (March 12, 2026).

How to tell if you have this one

Check if your ACUSON Sequoia ultrasound system has equipment serial numbers listed in the provided range (e.g., 800015 to 802273). The product label includes the model number 11148775 and power specifications.

Brand
Siemens
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Equipment Serial Number
Verify if your ACUSON Sequoia ultrasound system has an equipment serial number listed in the provided range (e.g., 800015 to 802273).

Where it went and when

Where it was distributed

Distributed in 43 states and Puerto Rico, and outside the U.S.

FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 2 months after the firm started it.

Feb 4, 2021Firm started the recall
Apr 1, 2021FDA classified it Class II
Apr 7, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Siemens recalls

Link to this recall

<a href="https://govinfonow.com/recall/63304-siemens-acuson-sequoia-ultrasound-system-may-cause-incorrect-delivery-date">Siemens ACUSON Sequoia Ultrasound System May Cause Incorrect Delivery Date Calculations (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1330-2021 (February 4, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1330-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.