Recall Z-0191-2022— FujiFilm Healthcare Americas Corporation

Name: FDA recall Z-0191-2022
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 one FDA 510(k) clearance: K162583. Product: Lisendo 880 Ultrasound Software Version: V1.0 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

1 on FDA's record

K162583 — ALOKA LISENDO 880Hitachi , Ltd.·cleared 2016-11-17

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

Lisendo 880 Ultrasound Software Version: V1.0 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.