BEUDAMED
    FDA Enforcement Class II Ongoing

    ACUSON Redwood 2.0 ultrasound systems, REF: 11503314

    Recall: Z-2582-2023 · Reported September 20, 2023

    Enforcement

    Recall Number
    Z-2582-2023
    Event ID
    92750
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 20, 2023
    Initiation Date
    July 13, 2023
    Classification Date
    September 13, 2023
    Address
    22010 Se 51st St, Issaquah, WA, 98029-7298, United States

    Description

    ACUSON Redwood 2.0 ultrasound systems, REF: 11503314

    Reason

    If a user-generated preset for an 18L6 transducer created on a 1.0 ultrasound system is used with a 2.0 ultrasound system, the 2.0 ultrasound system will display underestimated measurement results when using an 18L6 transducer and viewing in the Dual format visualization function, which may lead to misdiagnosis of a patient's condition or influence patient management decisions in a negative way.

    Code Info

    UDI-DI: 04056869251264. Systems with software version prefix VA20.

    Distribution

    Worldwide - US Nationwide distribution including in the states of IL, WI, CA, NM, TX, NC, MI, MD, NY, OH, IN, NE, PA, LA, SC, MO, OK, VA, ME, AZ, PR, IA, NH, NJ, AR, FL, SD and the countries of GR, ES, SG, TH, KR, IN, DE, TR, AT, IT, AU, JP, FR, CA, PT, SK, BR, SA, GB, NZ, RO, SE, AE, CN, HR, PL, CH, CR, IQ, NL, MX, ZA, BO, PH, MA, PA, EG, FJ, JO, DZ, TW, DK, CZ, CO, UG, CL, VN, CM, BG, QA, AZ, EC, KW, MY, PE, GG, SV, FO, ID, NP, BA, IL, LT, DO, IE.

    Quantity

    796