Recall Z-0190-2022— FujiFilm Healthcare Americas Corporation

Name: FDA recall Z-0190-2022
Creator: U.S. Food and Drug Administration
Published: 2021-10-14

Class II · Ongoing

Class II FDA medical device recall by FujiFilm Healthcare Americas Corporation, initiated 2021-10-14. It names 3 FDA 510(k) clearances: K183456, K173739, K171708. Product: Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3. 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: FujiFilm Healthcare Americas Corporation
Classification: Class II
Status: Ongoing
Initiated: 2021-10-14
Firm location: Twinsburg, OH, United States

510(k) clearances named in this recall

3 on FDA's record

K183456 — Aloka Arietta 850Hitachi Healthcare Americas·cleared 2019-01-28
K173739 — ALOKA ARIETTA 850Hitachi Healthcare Americas Corporation·cleared 2018-02-28
K171708 — ALOKA ARIETTA 850Hitachi Healthcare Americas Corporation·cleared 2017-10-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.