FDA Device recall Z-0189-2022
Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
- FDA Device
- Class II
- ongoing
- Published 2021-11-10
On 2021-11-10 the FDA classified a Class II recall of Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3 by Fujifilm Healthcare Americas, citing diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results cor….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0189-2022 |
| 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 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Reason
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.
Identifiers
| code_info | Serial Numbers: G3075073 (01)04562122959841(11)201214(21)G3075073; G3110777 (01)04562122959841(…Serial Numbers: G3075073 (01)04562122959841(11)201214(21)G3075073; G3110777 (01)04562122959841(11)210421(21)G3110777; G3110771 (01)04562122959841(11)210421(21)G3110771; G3113780 (01)04562122959841(11)210510(21)G3113780; G3113778 (01)04562122959841(11)210510(21)G3113778; G3113779 (01)04562122959841(11)210510(21)G3113779; G3113777 (01)04562122959841(11)210510(21)G3113777; G3071857 (01)04562122959841(11)210420(21)G3071857; G3108384 (01)04562122959841(11)210402(21)G3108384; G3114220 (01)04562122959841(11)210510(21)G3114220; G3110776 (01)04562122959841(11)210421(21)G3110776; G3108385 (01)04562122959841(11)210402(21)G3108385; G3114223 (01)04562122959841(11)210518(21)G3114223; G3108401 (01)04562122959841(11)210420(21)G310 |
|---|
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-0189-2022%22
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