Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
Recall
- Recall Number
- Z-1490-2026
- Event Number
- 98339
- Firm
- ESAOTE S.P.A. Sesto Fiorentino Via Degli Olmi 11 Sesto Fiorentino Italy
- FEI Number
- 3012981490
- Product Code
- ITX
- Status
- Completed
- Root Cause
- Process control
- Initiated
- March 14, 2025
- Posted
- March 3, 2026
Description
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 the cable.
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."
US: Nationwide distribution in the states of NC and TX.
5 units