BEUDAMED
    FDA Enforcement Class II Ongoing

    Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3

    Recall: Z-0189-2022 · Reported November 10, 2021

    Enforcement

    Recall Number
    Z-0189-2022
    Event ID
    88840
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    FujiFilm Healthcare Americas Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 10, 2021
    Initiation Date
    October 14, 2021
    Classification Date
    November 2, 2021
    Address
    1959 Summit Commerce Park, N/A, Twinsburg, OH, 44087-2371, United States

    Description

    Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3

    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.

    Code Info

    Serial Numbers: G3075073 (01)04562122959841(11)201214(21)G3075073; G3110777 (01)04562122959841(11)210421(21)G3110777; G3110771 (01)04562122959841(11)210421(21)G3110771; G3113780 (01)04562122959841(11)210510(21)G3113780; G3113778 (01)04562122959841(11)210510(21)G3113778; G3113779 (01)04562122959841(11)210510(21)G3113779; G3113777 (01)04562122959841(11)210510(21)G3113777; G3071857 (01)04562122959841(11)210420(21)G3071857; G3108384 (01)04562122959841(11)210402(21)G3108384; G3114220 (01)04562122959841(11)210510(21)G3114220; G3110776 (01)04562122959841(11)210421(21)G3110776; G3108385 (01)04562122959841(11)210402(21)G3108385; G3114223 (01)04562122959841(11)210518(21)G3114223; G3108401 (01)04562122959841(11)210420(21)G3108401; G3114959 (01)04562122959841(11)210524(21)G3114959

    Distribution

    Nationwide

    Quantity

    15 units