Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Reported: November 10, 2021 Initiated: October 14, 2021 #Z-0191-2022
Product Description
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Reason for Recall
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.
Details
- Recalling Firm
- FujiFilm Healthcare Americas Corporation
- Units Affected
- N/A
- Distribution
- Nationwide
- Location
- Twinsburg, OH
Frequently Asked Questions
What product was recalled? ▼
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3. Recalled by FujiFilm Healthcare Americas Corporation. Units affected: N/A.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 10, 2021. Severity: Moderate. Recall number: Z-0191-2022.
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