FujiFilm Arietta 65 Ultrasound Software V1.0-V4.00: Incorrect EROA Calculation Error
FujiFilm recalls Arietta 65 ultrasound software versions V1.0 through V4.0.0 due to incorrect calculation of Effective Regurgitant Orifice Area (EROA) when used with Fujifilm transducers, potentially leading to inaccurate heart flow measurements.
Lower-risk recall
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
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What happened, in plain English
FujiFilm is recalling Arietta 65 ultrasound software versions V1.0 through V4.0.0 because they incorrectly calculate heart flow measurements when used with Fujifilm transducers. This error could lead to inaccurate medical assessments if the software is used in clinical settings. Read more at govinfonow.com/recall/61687-fujifilm-arietta-65-ultrasound-software-v1-0-v4-00-incorrect.
Source Summary by GovInfoNow · govinfonow.com/recall/61687-fujifilm-arietta-65-ultrasound-software-v1-0-v4-00-incorrect · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0192-2022
Cite this page
“FujiFilm Arietta 65 Ultrasound Software V1.0-V4.00: Incorrect EROA Calculation Error.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61687-fujifilm-arietta-65-ultrasound-software-v1-0-v4-00-incorrect. Based on FDA recall #Z-0192-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0192-2022%22&limit=1).
Why it’s dangerous
The software error causes incorrect calculations of Effective Regurgitant Orifice Area (EROA) when performing specific heart flow measurements. This inaccuracy could lead to wrong medical assessments if the ultrasound system is used in clinical settings with the affected software versions and transducers.
Who’s affected
Healthcare providers using the Arietta 65 ultrasound system with Fujifilm transducers that have software versions V1.0 through V4.0.0 are affected. Medical professionals performing echocardiograms with these specific software versions are most at risk.
How to tell if you have this one
Check if your Arietta 65 ultrasound system has software versions V1.0 through V4.0.0. The serial numbers listed in the recall include specific UDI codes like G3024453, G3042466, and others.
- Brand
FujiFilm- Product
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0- Category
Medical device
What to do — step by step
Update Software
Contact FujiFilm Healthcare Americas to obtain the corrected software version for your Arietta 65 system.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 27 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using the software immediately?
No, the recall does not require immediate discontinuation of use. Healthcare providers should update to the corrected software version as soon as possible.
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Where this comes from
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-0192-2022 (October 14, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0192-2022 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.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.