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Open, Classified

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

FDA Recall Z-1330-2021 · Posted None

Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusOpen, Classified
Product CodeIYN
Date Initiated2021-02-04
Product Quantity1,172 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.

Firm Action

On 02/04/2021, the firm sent an "CUSTOMER SAFETY ADVISORY NOTIFICATION" email to customer informing them that 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. An incorrect EDD may influence patient management decisions regarding induction of labor and elective caesarean delivery, which may result in premature births. -Customers are instructed to avoid this issue, delete any MSD or GSD values from the patient report if other biometric parameters are measured. -Recalling Firm recommends a review of any early obstetric or gynecology ultrasound results for current pregnancies which produced a gestational age using MSD or GSD as an input. -The issue will be corrected by the Recalling Firm with an updated to the software and a Customer Service Engineer will contact customers to schedule a facility visit to update the software or updates will be issued via the Remote Update Handling process. -Customers are instructed to inform their personnel accordingly. Additional questions or assistance - contact Quality & Regulatory at 732-331-6672 or email [email protected].

Root Cause

Software Design Change

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K193257ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2020-01-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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