Recall of Siemens ACUSON Sequoia ultrasound systems with software version VA25A/B due to measurement error in 2D trace tool potentially causing misdiagnosis. Affected units have specific serial numbers listed.
Due to a calculation error in the measurement when using 2D trace (manual trace) tool. The trace circumference value is overestimated and may potentially result in misdiagnosis of a patient's condition.
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Contact the company
📍Recalling firmSiemens Medical Solutions USA, Inc.22010 SE 51st St · Issaquah, WA 98029-7298
✎ GovInfoNow plain-language explainer
Siemens is recalling ACUSON Sequoia ultrasound imaging systems with software version VA25A/B because a calculation error in the 2D trace tool may overestimate the circumference of measurements, leading to potential misdiagnosis of patient conditions. This recall affects specific units with listed serial numbers. Read more at govinfonow.com/recall/61545-siemens-acuson-sequoia-ultrasound-system-software-va25a-b-recall-measurement.
“Siemens ACUSON Sequoia Ultrasound System Software VA25A/B Recall: Measurement Error Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61545-siemens-acuson-sequoia-ultrasound-system-software-va25a-b-recall-measurement. Based on FDA recall #Z-0547-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0547-2022%22&limit=1).
The FDA announced on Nov. 12, 2021, that Siemens Medical Solutions USA, Inc. is recalling ACUSON Sequoia Ultrasound Imaging Systems with software version VA25A/B due to a calculation error in the 2D trace tool that may result in patient misdiagnosis. Owners should contact Siemens for remedy details.
How to tell if you have it
Brand: Siemens Medical Solutions
Product: ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
System Serial Numbers: 800101 through 802972 (specific codes listed in record)
Quantity: 1161 systems
The hazard
The recall is due to a calculation error in the measurement when using the 2D trace (manual trace) tool. The trace circumference value is overestimated and may potentially result in misdiagnosis of a patient's condition.
Context
GovInfoNow's records show Siemens Medical Solutions USA, Inc. has 182 other recalls on record since June 6, 2017. Recent similar product recalls include the PIE Medical Imaging 3mensio Workstation Software Recall (May 7, 2026), the Philips EPIQ Elite Ultrasound System Recall (Aug. 7, 2026), and the Intelerad InteleShare Software Recall (Nov. 18, 2025).
How to tell if you have this one
Check if your ACUSON Sequoia ultrasound system has software version VA25A/B. Affected units have specific serial numbers listed in the recall notice, including 800101 through 802999.
Brand
Siemens Medical Solutions
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your system's software version by checking the device settings or documentation. If it is VA25A/B, it is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 43 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CN, DE, FL, GA, HI, IL, IN, IA, KS, KY, LA, MD, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, 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 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0547-2022 (November 12, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0547-2022 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.