Genova, IT · 11 510(k) clearances · 3 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Class II | Radiology | 6 | 2026-04-06 |
| LNH | — | — | — | 5 | 2026-07-31 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-03-14 | Class II | Completed | Z-1490-2026 | Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038 | — | A potential weakness has been identified in the probe body, so that, in a specific production batch, liquid may leak from the terminal part of the casing near t… |
| 2020-09-08 | Class II | Terminated | Z-3053-2020 | AC/DC POWER SUPPLY for 7400, Part Number 151004301, XP Power Model Number AHM180PS19-XE1057, AC/DC Adapter associated wi… | — | The AC/DC adapter (power supply) of the portable ultrasound systems listed below that may result in the connector heating up, generating smoke and melting. T… |
| 2020-09-08 | Class II | Terminated | Z-3052-2020 | AC/DC POWER SUPPLY for 7400, Part Number 151004300, XP Power Model Number AHM180PS19-XE0338, AC/DC Adapter associated wi… | — | The AC/DC adapter (power supply) of the portable ultrasound systems listed below that may result in the connector heating up, generating smoke and melting. T… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-07-31 | K261331 | I-Genius (100019400) | LNH | — | — |
| 2026-04-06 | K253288 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | IYN | Class II | Radiology |
| 2026-03-27 | K260746 | S-scan Open (100001800) | LNH | — | — |
| 2026-03-05 | K251901 | Magnifico Open (100009900) | LNH | — | — |
| 2025-11-25 | K253310 | 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) | IYN | Class II | Radiology |
| 2025-06-18 | K243253 | 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) | IYN | Class II | Radiology |
| 2025-05-16 | K241671 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | IYN | Class II | Radiology |
| 2024-06-26 | K241133 | Magnifico Open (100009900); Magnifico MSK ( 100009910) | LNH | — | — |
| 2023-11-29 | K230179 | 6440 MyLabX90 | IYN | Class II | Radiology |
| 2022-02-04 | K212419 | Magnifico Open, Magnifico MSK | LNH | — | — |
| 2021-09-16 | K212021 | 6430 MyLabX75, 6430 MyLab XPro75 | IYN | Class II | Radiology |