FDAOctober 14, 2021device
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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
What to do
FDA enforcement status: Ongoing
Brands named
fujifilm healthcare americasfujifilmfujifilm healthcare
UPCs
04562122959278
Recall history
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