FDA Device recall Z-0192-2022
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
- FDA Device
- Class II
- ongoing
- Published 2021-11-10
On 2021-11-10 the FDA classified a Class II recall of Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0 by Fujifilm Healthcare Americas, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0192-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-10-14 |
| Published | 2021-11-10 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Fujifilm Healthcare Americas |
| Distribution | US |
Product
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
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
Identifiers
| code_info | Serial Numbers/UDI: G3024453 (01)04562122959278(11)191029(21)G3024453 G3024456 (01)04562122959278(11)191029(21)G3024456…Serial Numbers/UDI: G3024453 (01)04562122959278(11)191029(21)G3024453 G3024456 (01)04562122959278(11)191029(21)G3024456 G3042466 (01)04562122959278(11)191115(21)G3042466 G3042471 (01)04562122959278(11)191115(21)G3042471 G3042477 (01)04562122959278(11)191115(21)G3042477 G3042478 (01)04562122959278(11)191115(21)G3042478 G3042484 (01)04562122959278(11)191115(21)G3042484 G3042486 (01)04562122959278(11)191115(21)G3042486 G3042487 (01)04562122959278(11)191115(21)G3042487 G3042496 (01)04562122959278(11)191115(21)G3042496 G3042499 (01)04562122959278(11)191115(21)G3042499 G3042501 (01)04562122959278(11)191115(21)G3042501 G3042576 (01)04562122959278(11)191220(21)G3042576 G3042578 (01)04562122959278(11)191220(21)G3042578 G3042583 (01)04562122959278(11)191220(21)G3042583 G3042584 (01)04562122959278(11)191205(21)G3042584 G3042585 (01)04562122959278(11)191205(21)G3042585 G3042587 (01)04562122959278(11)191205(21)G3042587 G3042588 (01)04562122959278(11)191220(21)G3042588 G3082956 (01)04562122959278(11 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0192-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.