Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
FDA device recall Z-1490-2026 · posted 2026-03-03 · Completed
Recall details
- Recalling firm
- ESAOTE S.P.A.
- Reason for recall
- 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.
- Action taken
- 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 current status of the device. As a precautionary measure, and to complete the root cause analysis while improving our processes and customer service, Esaote will proceed with a voluntary precautionary recall. Our Technical Support Service will soon contact customers who own the affected units to arrange for the replacement of the probe."
- Root cause
- Process control
- Status
- Completed
- Product code
- ITX
- Quantity affected
- 5 units
- Distribution
- US: Nationwide distribution in the states of NC and TX.
- Date initiated
- 2025-03-14
- Date posted
- 2026-03-03
- Location
- Sesto Fiorentino, Italy
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 6440 MyLabX90 (K230179) | Esaote, S.p.A. | 2023-11-29 |