FDA recall Z-0189-2022

Product

Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3

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.

Distribution

Nationwide

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-0189-2022