FDAOctober 14, 2021device
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
fujifilm healthcare americasfujifilmfujifilm healthcare
UPCs
04562122958868
Recall history
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