FDA-Device2021-11-10Class II
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
FujiFilm Healthcare Americas Corporation
Hazard
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
Sold states
US Nationwide distribution.
Affected count
48 US
Manufactured in
1959 Summit Commerce Park, N/A, Twinsburg, OH, United States
Products
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0192-2022Don't want to check this manually?
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