Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0 Recalled by FujiFilm Healthcare Americas Corporation Due to When the ultrasound system is used in combination...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact FujiFilm Healthcare Americas Corporation directly.
Affected Products
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
Quantity: 48 US
Why Was This Recalled?
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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About FujiFilm Healthcare Americas Corporation
FujiFilm Healthcare Americas Corporation has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report