Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
- Recall Initiated
- March 14, 2025
- Posted
- March 3, 2026
- Recall Number
- Z-1490-2026
- Quantity
- 5 units
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.
Distribution
US: Nationwide distribution in the states of NC and TX.
Lot / Code Info
UDI 0805604453891, Serial Numbers: 241700533C, 241700529C, 241700607C, 241700536C, 241700613C.
Root Cause
Process control
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."