FDAHealthMarch 14, 2025
ESAOTE S.P.A. — 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 14, 2025
US: Nationwide distribution in the states of NC and TX.
What's affected?
- Product
- Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
- Brand
- ESAOTE S.P.A.
- Lot code
- UDI 0805604453891, Serial Numbers: 241700533C, 241700529C, 241700607C, 241700536C, 241700613C.
Additional details
UDI 0805604453891, Serial Numbers: 241700533C, 241700529C, 241700607C, 241700536C, 241700613C.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 5 units.
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