Official recall notice
FDA DeviceClass IINotable
FDA Recall: Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
- Recall date
- 2026-03-11
- Brand
- ESAOTE S.P.A.
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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.
Recommended action
What to do
5 units
Product 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.