# FDA recall Z-0190-2022

> **FujiFilm Healthcare Americas Corporation** · Class II · device recall initiated 2021-10-14.

## Product

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.

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-0190-2022
- **Recalling firm:** FujiFilm Healthcare Americas Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-10-14
- **Report date:** 2021-11-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Twinsburg, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0190-2022

## Citation

> AI Analytics. FDA recall Z-0190-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0190-2022. Source: US FDA. Licensed CC0.

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