BEUDAMED
    FDA Recall Open, Classified

    Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3

    Recall: Z-0190-2022 · Initiated October 14, 2021

    Recall

    Recall Number
    Z-0190-2022
    Event Number
    88840
    Firm
    FujiFilm Healthcare Americas Corporation
    FEI Number
    1528028
    Product Code
    IYN
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    October 14, 2021
    Address
    1959 Summit Commerce Park, Twinsburg, OH, 44087-2371

    Description

    Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3

    Reason

    Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement; Mitral Valve (MV) Measurement. In addition there is an error in the instruction manual.

    Action

    Fujifi Film issued Medical Device Correction Notice letter dated 10/07/21 via courier on 10/14/21. Letter states reason for recall, health risk and action to take: Customers/Users are advised to accept the corrected software and manual as soon as available. Advisory Notification applies to all customers and distributors of the ARIETTA 850 systems with software version V1.0.0 through V4.1.3, See following page for complete list of affected systems. We will contact you to set up time to update the software and provide the revised manual. (7) Other Information: For questions, comments, or concerns, please contact: Aaron Pierce Director, QA/RA 1959 Summit Commerce Park Twinsburg, OH 44087 Phone (330) 425-1313 x2934, Fax (330) 963-0749 Email [email protected]

    Distribution

    Nationwide

    Quantity

    38 units