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FujiFilm Healthcare Americas Corporation recalls Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
Recalled November 10, 2021 · FDA recall Z-0192-2022 · FujiFilm Healthcare Americas
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 · FDA Class II
Units
48 US
Sold at
US Nationwide distribution.
Description
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
Product
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
Manufacturer(s)
FujiFilm Healthcare Americas Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →