Arietta 65 Ultrasound Software Versions: V1 — Class II medical device recall Z-0192-2022
Ongoing recall by FujiFilm Healthcare Americas Corporation, reported 2021-11-10, distributed nationwide. When the ultrasound system is used in combination with a Fujifilm (formally Hitachi) transducer, there is an e
| Recall number | Z-0192-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | FujiFilm Healthcare Americas Corporation, Twinsburg, OH, United States |
| Recall initiated | 2021-10-14 |
| Classified | 2021-11-02 |
| Reported by FDA | 2021-11-10 |
| Distributed | Nationwide (US) |
| Quantity | 48 us |
| UPC / GTIN / UDI-DI | 04562122959278 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0192-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.