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. Read more at govinfonow.com/recall/61684-fujifilm-arietta-850-ultrasound-software-v1-0-0-v4-1.
“FujiFilm Arietta 850 Ultrasound Software V1.0.0-V4.1.3: Incorrect Cardiac Measurements.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61684-fujifilm-arietta-850-ultrasound-software-v1-0-0-v4-1. Based on FDA recall #Z-0190-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0190-2022%22&limit=1).
The FDA announced on Oct. 14, 2021, that FujiFilm Healthcare Americas Corporation is recalling Arietta 850 Ultrasound systems with software versions V1.0.0 through V4.1.3 because they may not display measurement results correctly for two cardiology functions. The agency said the recall is voluntary and ongoing.
How to tell if you have it
Brand: FujiFilm
Product: Arietta 850 Ultrasound
Software Version: V1.0.0 through V4.1.3
UPC: 04562122958974
The hazard
The diagnostic ultrasound system used with a Fujifilm transducer does not display measurement results correctly for Mitral Regurgitation Flow Measurement and Mitral Valve Measurement. The recall also cites an error in the instruction manual.
Context
GovInfoNow's records show FujiFilm Healthcare Americas Corporation has 13 other recalls on record since Oct. 14, 2021. Other recent recalls of similar products include FUJIFILM Synapse PACS Software v7.4.310 (July 22, 2026), FUJIFILM FDR Visionary Suite CH-200 X-ray Device Recall (Jan. 9, 2026), and FUJIFILM FDR Visionary Suite CH-200 X-ray Tube Shaft Break Risk (Sept. 15, 2025). Other recent recalls of similar products include PIE Medical Imaging 3mensio Workstation Software Recall (May 7, 2026), Philips EPIQ Elite Ultrasound System Recall (Aug. 7, 2026), and Philips Cardiac Workstation 7000 (July 1, 2026).
How to tell if you have this one
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.
Brand
FujiFilm
Product
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
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.
Official source: FDA Recall #Z-0190-2022 (October 14, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0190-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
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