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.
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
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.
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.
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.
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.
Contact FujiFilm Healthcare Americas to obtain the corrected software version for your Arietta 65 system.
Software versions V1.0 through V4.0.0 are affected.
Check your system's serial numbers against the list provided in the recall, which includes specific UDI codes like G3024453, G3042466, and others.
No, the recall does not require immediate discontinuation of use. Healthcare providers should update to the corrected software version as soon as possible.
We’ve drafted a message you can send FujiFilm to request your refund or repair — edit it as you like.
Subject: Recall Z-0192-2022 — FujiFilm FujiFilm Hello, I own a FujiFilm that is covered by recall Z-0192-2022 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.
