FDA recall Z-0192-2022

Product

Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0

Reason for recall

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

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2021-10-14

Report date

2021-11-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Twinsburg, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0192-2022