FDA DeviceClass IINotable

FDA Recall: Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038

Name: FDA Recall: Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
Brand: ESAOTE S.P.A.

Date: 2026-03-11

Brand: ESAOTE S.P.A.

Category: Medical Device

FDA Class: Class II

Description

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.

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.