FDA DevicesClass II
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
Published: March 11, 2026Recall ID: Z-1490-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
Additional Source Details
| Field | Value |
|---|---|
| City | Sesto Fiorentino |
| State | N/A |
| Event id | 98339 |
| Address 1 | Sesto Fiorentino |
| Address 2 | Via Degli Olmi 11 |
| Code info | UDI 0805604453891, Serial Numbers: 241700533C, 241700529C, 241700607C, 241700536C, 241700613C. |
| Postal code | N/A |
| Report date | 20260311 |
| Product type | Devices |
| Product 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20250314 |
| Initial firm notification | Letter |
| Center classification date | 20260303 |
Overview
- Recalling FirmESAOTE S.P.A.
- StatusCompleted
- Risk LevelClass II
- DistributionUS: Nationwide distribution in the states of NC and TX.