10

Nov

2021

Recall – Ultrasound measurement results displayed incorrectly

recall, softwareerror

0

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

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