BEUDAMED
    FDA Recall 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

    Recall: Z-1330-2021 · Initiated February 4, 2021

    Recall

    Recall Number
    Z-1330-2021
    Event Number
    87362
    Firm
    Siemens Medical Solutions USA, Inc.
    FEI Number
    3023245
    Product Code
    IYN
    Status
    Open, Classified
    Root Cause
    Software Design Change
    Initiated
    February 4, 2021
    Address
    22010 SE 51st St, Issaquah, WA, 98029-7298

    Description

    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

    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.

    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].

    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

    Quantity

    1,172 systems