Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | completed |
| Recall date | March 14, 2025 |
| Reported | March 11, 2026 |
| Recalling firm | ESAOTE S.P.A. |
| Country / region | Italy N/A |
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.
Affected products
- Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
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