FDA-Device2026-03-11Class II
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
ESAOTE S.P.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.
Sold states
US: Nationwide distribution in the states of NC and TX.
Affected count
5 units
Manufactured in
Sesto Fiorentino, Via Degli Olmi 11, Sesto Fiorentino, N/A, Italy
Products
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1490-2026Original summary
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038 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. UDI 0805604453891, Serial Numbers: 241700533C, 241700529C, 241700607C, 241700536C, 241700613C. Distribution: US: Nationwide distribution in the states of NC and TX. Affected quantity: 5 units
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