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

Medical DevicesSource: FDA (device) · Date: 2026-03-11

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
ESAOTE S.P.A.
Product
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
Reason / 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.
Classification
Class II
Status
Completed
Distribution / sold at
US: Nationwide distribution in the states of NC and TX.
Recall initiated
2025-03-14
Code info
UDI 0805604453891, Serial Numbers: 241700533C, 241700529C, 241700607C, 241700536C, 241700613C.
Product quantity
5 units
Voluntary mandated
Voluntary: Firm initiated
City
Sesto Fiorentino
State
N/A
Country
Italy
Event id
98339
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