Recall Z-1490-2026— ESAOTE S.P.A.
Class II · Completed
Class II FDA medical device recall by ESAOTE S.P.A., initiated 2025-03-14. It names one FDA 510(k) clearance: K230179. Product: Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038. Reason: 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..
- Recalling firm
- ESAOTE S.P.A.
- Classification
- Class II
- Status
- Completed
- Initiated
- 2025-03-14
- Firm location
- Sesto Fiorentino, N/A, Italy
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.