Drug recall
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
FDA recall event 88849 · Class II · FujiFilm Healthcare Americas Corporation
Key facts
| Event ID | 88849 |
|---|---|
| Recall numbers | Z-0192-2022 |
| Recalling firm | FujiFilm Healthcare Americas Corporation |
| Product type | Devices |
| Products | Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Oct 14, 2021 |
| Report date | Nov 10, 2021 |
| City | Twinsburg |
| State | OH |
| Country | United States |
| FEI number | 1528028 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: