BEUDAMED
    FDA Recall Open, Classified

    ACUSON Redwood 2.0 ultrasound systems, REF: 11503314

    Recall: Z-2582-2023 · Initiated July 13, 2023

    Recall

    Recall Number
    Z-2582-2023
    Event Number
    92750
    Firm
    Siemens Medical Solutions USA, Inc.
    FEI Number
    3023245
    Product Code
    IYN
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    July 13, 2023
    Posted
    September 13, 2023
    Address
    22010 Se 51st St, Issaquah, WA, 98029-7298

    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.

    Action

    On 7/13/23, correction notices were emailed, mailed, or delivered to customers who were asked to do the following: What if I imported my user-generated presets of an 18L6 transducer from an ACUSON Redwood 1.0 system onto an ACUSON Redwood 2.0 system, then used an 18L6 transducer with Dual format to perform patient examinations using my ACUSON Redwood 2.0 system? Review any ultrasound examination results obtained in this situation. Only measurements taken from an 18L6 transducer within Dual format on ACUSON Redwood 2.0 systems are impacted. Ensure that all users of affected ultrasound systems within your organization, and others who may need to be informed, receive the relevant safety information provided with this notice and take the actions specified herein. Your Customer Service Engineer will contact you to schedule a facility visit to update the system or inform you of a remote update when the software update is available. The software update is currently under development and estimated to be available by fall of 2023. Customers with additional questions can contact customer service at 1-800-888-7436.

    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