Company: FujiFilm Healthcare Americas Corporation
Date of Enforcement Report: 11/10/2021
Class II
PRODUCT
Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Recall Number: Z-0189-2022
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Recall Number: Z-0190-2022
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Recall Number: Z-0191-2022
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
Recall Number: Z-0192-2022
REASON
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.
RECALLING FIRM/MANUFACTURER
FujiFilm Healthcare Americas Corporation on 10/14/2021. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
U.S. Nationwide