Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3 Recalled by FujiFilm Healthcare Americas Corporation Due to Diagnostic ultrasound system with the specified software version...
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
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Quantity: N/A
Why Was This Recalled?
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.
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