ESAOTE S.P.A.: Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
Read the official notice at FDA (device) →
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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