# FDA recall Z-0192-2022

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

## Product

Arietta 65 Ultrasound  Software Versions:  V1.0 through V4.0.0

## Reason for recall

When the ultrasound system is used in combination with a Fujifilm (formally Hitachi) transducer, there is an error in the calculation formula of Effective Regurgitant Orifice Area (EROA) when you perform MR Flow combined with Left Ventricular Outflow Tract Flow (LVOT Flow) after performing an echocardiogram. The incorrect value is displayed. In addition, the error appears in the instruction manual

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0192-2022
- **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-0192-2022

## Citation

> AI Analytics. FDA recall Z-0192-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0192-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*