Recalled FujiFilm Arietta 850 ultrasound systems with specific software versions (V1.0.0 to V4.1.3) may show incorrect mitral regurgitation and valve measurements, risking inaccurate cardiac diagnoses.
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 recalls Arietta 850 ultrasound systems with software versions from V1.0.0 to V4.1.3 because they display cardiac measurements incorrectly. This could lead to wrong diagnoses for mitral regurgitation and valve issues, which is serious for patients needing accurate heart assessments.
The software error causes the system to display incorrect measurements for mitral regurgitation flow and mitral valve function. This could lead to inaccurate cardiac assessments, potentially resulting in wrong treatment decisions for heart conditions.
Healthcare providers using the Arietta 850 ultrasound system with the specified software versions are affected. Patients undergoing cardiac imaging with these systems may be at risk of incorrect diagnoses.
Check if your Arietta 850 ultrasound has software versions V1.0.0 through V4.1.3. Serial numbers listed in the recall include patterns like 205W3386, 206F7900, and G3002552.
Look for the software version on your Arietta 850 ultrasound system; if it is between V1.0.0 and V4.1.3, it is affected.
Reach out to FujiFilm Healthcare Americas Corporation for guidance on next steps if your system is affected.
The software error causes incorrect measurements for mitral regurgitation flow and mitral valve function, which could lead to inaccurate cardiac diagnoses.
Check the software version on your system; affected units have versions from V1.0.0 to V4.1.3, with specific serial numbers listed in the recall notice.
Contact FujiFilm Healthcare Americas Corporation for instructions on next steps; the recall does not include a fix or replacement.
We’ve drafted a message you can send FujiFilm to request your refund or repair — edit it as you like.
Subject: Recall Z-0190-2022 — FujiFilm FujiFilm Hello, I own a FujiFilm that is covered by recall Z-0190-2022 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.
