BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-0190-2022 · Reported November 10, 2021

    Enforcement

    Recall Number
    Z-0190-2022
    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 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.

    Code Info

    Serial Numbers: 205W3386 (01)04562122958974(11)171114(21)205W3386; 206F7900 (01)04562122958974(11)180926(21)206F7900; 206F7901 (01)04562122958974(11)180926(21)206F7901; 206F7936 (01)04562122958974(11)181113(21)206F7936; 206F7937 (01)04562122958974(11)181113(21)206F7937; 206F7940 (01)04562122958974(11)181113(21)206F7940; 206F7941 (01)04562122958974(11)181113(21)206F7941; 206F7942 (01)04562122958974(11)181113(21)206F7942; 206F7944 (01)04562122958974(11)181113(21)206F7944; 206F7945 (01)04562122958974(11)181113(21)206F7945; 206F7946 (01)04562122958974(11)181113(21)206F7946; 206F7947 (01)04562122958974(11)181114(21)206F7947; G3002552 (01)04562122958974(11)20190115(21)G3002552; G3024545 (01)04562122958974(11)190607(21)G3024545; G3037885 (01)04562122958974(11)20190719(21)G3037885; G3037887 (01)04562122958974(11)20190719(21)G3037887; G3042405 (01)04562122958974(11)190829(21)G3042405; G3042823 (01)04562122958974(11)20190807(21)G3042823; G3042828 (01)04562122958974(11)20190808(21)G3042828; G3045094 (01)04562122958974(11)20190822(21)G3045094; G3052105 (01)04562122958974(11)20191008(21)G3052105 G3052118 (01)04562122958974(11)20191025(21)G3052118 G3055549 (01)04562122958974(11)20191118(21)G3055549 G3055550 (01)04562122958974(11)20191118(21)G3055550 G3055552 (01)04562122958974(11)20191118(21)G3055552 G3055553 (01)04562122958974(11)20191118(21)G3055553 G3055554 (01)04562122958974(11)20191118(21)G3055554 G3055555 (01)04562122958974(11)20191118(21)G3055555 G3060234 (01)04562122958974(11)20191206(21)G3060234 G3060254 (01)04562122958974(11)20191206(21)G3060254 G3060275 (01)04562122958974(11)20191216(21)G3060275 G3060278 (01)04562122958974(11)20191216(21)G3060278 G3060690 (01)04562122958974(11)200127(21)G3060690 G3071074 (01)04562122958974(11)20200227(21)G3071074 G3080785 (01)04562122958974(11)201105(21)G3080785 G3090450 (01)04562122958974(11)201225(21)G3090450 G3110884 (01)04562122958974(11)210401(21)G3110884

    Distribution

    Nationwide

    Quantity

    38 units