Arietta 850 Ultrasound- Software Version: V1 — Class II medical device recall Z-0190-2022
Ongoing recall by FujiFilm Healthcare Americas Corporation, reported 2021-11-10, distributed nationwide. Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (form
| Recall number | Z-0190-2022 |
|---|---|
| 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 | 38 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 04562122958974 |
| Serial numbers | 205W3386 |
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.
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-0190-2022. 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.