Recall Z-1490-2026 ยท ITX Transducer, Ultrasonic, Diagnostic
ESAOTE S.P.A.
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
| Date | Mar 3, 2026 (initiated Mar 14, 2025) |
| Status | Completed |
| Reason | 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 the cable. |
| Root cause | Process control |
| Action | Esaote issued a Field Safety Notice to its consignees on 3/14/2025 via FedEx. The notice explained the problem with the device, potential risk of use and requested the following: "Actions to be performed by the user " If the operator detects the issue during the inspection, they must NOT use the probe and should contact Esaote's technical support. " Please distribute this Safety Notice to all personnel involved within your organization and to all users of the device. " If the device is no longer in your possession, please provide Esaote with the new owner's details or inform us about the |
| Quantity | 5 units |
| Distribution | US: Nationwide distribution in the states of NC and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K230179 | 6440 MyLabX90 Esaote, S.p.A., Nov 29, 2023 |