# FDA recall Z-0547-2022

> **Siemens Medical Solutions USA, Inc.** · Class II · device recall initiated 2021-11-12.

## Product

ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

## Reason for recall

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.

## 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, VA, WA, WV, WI, and WY. The countries of United Arab Emirates, Armenia, Angola, Austria, Australia, Azerbaijan, Bangladesh, Belgium, Bahrain, Brazil, Switzerland, Chile, China, Colombia, Cyprus, Czech Republic, Germany, Denmark, Dominican Rep., Egypt, Spain, Finland, France, United Kingdom, Georgia, Greece, Guatemala, Hong Kong, Croatia, Indonesia, Israel, Iceland, Italy, Japan, Republic Korea, Kuwait, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, Poland, Portugal, Qatar, Romania, Serbia, Russian Fed., Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Turkey, Taiwan, Ukraine, South Africa.

## Key facts

- **Recall number:** Z-0547-2022
- **Recalling firm:** Siemens Medical Solutions USA, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-11-12
- **Report date:** 2022-02-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Issaquah, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0547-2022

## Citation

> AI Analytics. FDA recall Z-0547-2022. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0547-2022. Source: US FDA. Licensed CC0.

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