FDA-Device2021-11-10Class II
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
FujiFilm Healthcare Americas Corporation
Hazard
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.
Sold states
Nationwide
Affected count
38 units
Manufactured in
1959 Summit Commerce Park, N/A, Twinsburg, OH, United States
Products
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0190-2022Don't want to check this manually?
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