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FujiFilm Healthcare Americas Corporation recalls Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Recalled November 10, 2021 · FDA recall Z-0189-2022 · FujiFilm Healthcare Americas
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. · FDA Class II
Units
15 units
Sold at
Nationwide
Description
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.
Product
Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Manufacturer(s)
FujiFilm Healthcare Americas Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →