Recalled FujiFilm Lisendo 880 ultrasound software versions V1.0 to V4.1.3 may display incorrect mitral regurgitation flow and valve measurements. Affected units have specific serial numbers.
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 Healthcare recalls ultrasound software versions V1.0 through V4.1.3 for the Lisendo 880 system. These versions incorrectly show cardiac measurements like mitral regurgitation flow and valve function, which could lead to inaccurate diagnoses if used without correction.
The software versions V1.0 to V4.1.3 fail to display mitral regurgitation flow and mitral valve measurements correctly when used with Fujifilm transducers. This error could lead to inaccurate cardiac assessments if the software is not updated to a corrected version.
Healthcare providers using the Lisendo 880 ultrasound system with the recalled software versions are affected. Patients receiving cardiac ultrasounds with these faulty software versions may receive incorrect measurements.
Check if your Lisendo 880 ultrasound system has software versions V1.0 through V4.1.3. Affected units have specific serial numbers listed in the recall notice.
Verify your Lisendo 880 ultrasound software version by checking the system settings or documentation.
The software error may cause incorrect cardiac measurements, but it does not pose an immediate risk to patients or users. Corrective action is needed to ensure accurate results.
Check if your Lisendo 880 software version is between V1.0 and V4.1.3. Affected units have specific serial numbers listed in the recall notice.
Contact FujiFilm Healthcare to confirm your software version and serial number. They will provide instructions for updating to a corrected version if needed.
We’ve drafted a message you can send FujiFilm Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0191-2022 — FujiFilm Healthcare FujiFilm Healthcare Hello, I own a FujiFilm Healthcare that is covered by recall Z-0191-2022 from FujiFilm Healthcare. 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.
