BEUDAMED
    FDA Recall Open, Classified

    Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0

    Recall: Z-0192-2022 · Initiated October 14, 2021

    Recall

    Recall Number
    Z-0192-2022
    Event Number
    88849
    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 65 Ultrasound Software Versions: V1.0 through V4.0.0

    Reason

    When the ultrasound system is used in combination with a Fujifilm (formally Hitachi) transducer, there is an error in the calculation formula of Effective Regurgitant Orifice Area (EROA) when you perform MR Flow combined with Left Ventricular Outflow Tract Flow (LVOT Flow) after performing an echocardiogram. The incorrect value is displayed. In addition, the error appears in the instruction manual

    Action

    Fujifilm issued Urgent Medical Device Correction letter dated 10/7/21, mailed 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. The Advisory Notification applies to all customers and distributors of the ARIETTA 65 system with software version V1.0 through V4.0.0. We will contact you to set up time to update the software and provide the revised manual. 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

    US Nationwide distribution.

    Quantity

    48 US