Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Product Label - ACUSON Sequoia *** Power Input: 100-240V~ Recalled by Siemens Medical Solutions USA, Inc. Due to The ultrasound system averages the Mean Sac Diameter...

Date: February 4, 2021
Company: Siemens Medical Solutions USA, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Medical Solutions USA, Inc. directly.

Affected Products

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

Quantity: 1,172 systems

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 43 states: AL, AK, AZ, AR, CA, CT, DE, FL, GA, HI, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI, WY

Affected (43 states)Not affected

About Siemens Medical Solutions USA, Inc.

Siemens Medical Solutions USA, Inc. has 87 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report