# FDA recall Z-1330-2021

> **Siemens Medical Solutions USA, Inc.** · Class II · device recall initiated 2021-02-04.

## Product

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

## Reason for 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.

## 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, 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

## Key facts

- **Recall number:** Z-1330-2021
- **Recalling firm:** Siemens Medical Solutions USA, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-02-04
- **Report date:** 2021-04-07

- **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-1330-2021

## Citation

> AI Analytics. FDA recall Z-1330-2021. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1330-2021. Source: US FDA. Licensed CC0.

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