Device product
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
Z-1490-2026
Product summary
- Firm
- ESAOTE S.P.A.
- Event
- Event 98339
- Status
- Completed
- Classification
- Class II
- Quantity
- 5 units
- Official record key
device-enforcement:Z-1490-2026
Official wording
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.
Code information: UDI 0805604453891, Serial Numbers: 241700533C, 241700529C, 241700607C, 241700536C, 241700613C.
Distribution pattern: US: Nationwide distribution in the states of NC and TX.
Derived failure modes
-
Unknown
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.