FDA-Device2026-03-11Class IIPACKAGING DEFECT
Esaote Model E 3-12 endocavity ultrasound probe recalled for potential liquid leakage
What this means
Esaote has identified a weakness in the probe body on a specific production batch that may cause liquid to leak from the cable connection area. Five units with specific serial numbers were distributed in North Carolina and Texas.
- Check if your Esaote E 3-12 probe serial number matches one of these: 241700533C, 241700529C, 241700607C, 241700536C, or 241700613C
- Stop using the probe if it matches one of these serial numbers
- Contact Esaote for replacement or repair instructions
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
US: Nationwide distribution in the states of NC and TX.
Affected count
5 units
Manufactured in
Sesto Fiorentino, Via Degli Olmi 11, Sesto Fiorentino, N/A, Italy
Products
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1490-2026Want us to check the next one for you?
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