FujiFilm recalls Arietta 750 ultrasound software versions V1.0.0 to V2.1.3 due to incorrect measurements for mitral regurgitation and valve function. Affected units may display wrong results during cardiac scans.
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.
FujiFilm is recalling specific versions of its Arietta 750 ultrasound software (V1.0.0 to V2.1.3) because they don't show mitral regurgitation flow and valve measurements correctly. This could lead to inaccurate cardiac assessments if used with Fujifilm transducers.
The software versions fail to display two critical cardiac measurements correctly when used with Fujifilm transducers. This error occurs in the ultrasound system's display, potentially leading to inaccurate diagnosis of heart conditions.
Healthcare providers using the Arietta 750 ultrasound system with the specified software versions are most at risk. Patients receiving cardiac scans with these systems may receive incorrect measurements.
Check if your Arietta 750 ultrasound system has software versions V1.0.0 through V2.1.3. Serial numbers listed in the recall include G3075073, G3110777, and others.
Look for the software version on your Arietta 750 system to confirm if it is V1.0.0 through V2.1.3.
The software versions V1.0.0 through V2.1.3 do not display mitral regurgitation flow and valve measurements correctly when used with Fujifilm transducers, and there is an error in the instruction manual.
Check your software version and serial number against the list provided in the recall notice, which includes specific serial numbers like G3075073 and G3110777.
The recall does not specify a remedy, so contact FujiFilm Healthcare Americas Corporation directly for guidance.
We’ve drafted a message you can send FujiFilm to request your refund or repair — edit it as you like.
Subject: Recall Z-0189-2022 — FujiFilm FujiFilm Hello, I own a FujiFilm that is covered by recall Z-0189-2022 from FujiFilm. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
