Class II — FujiFilm Healthcare Americas Corporation
| Recalling firm | FUJIFILM Healthcare Americas Corporation |
|---|---|
| Registered facility | FUJIFILM Healthcare Americas Corporation (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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 |
| Product | Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0 |
| Quantity | 48 US |
| Distribution | US Nationwide distribution. |
| Initiated | 2021-10-14 |
| Classified | 2021-11-02 |
| Recall number | Z-0192-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — FujiFilm Healthcare Americas Corporation (Z-0192-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88849/
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