[pending] Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
Pending LLM rewrite. Source: FDA_DEVICE Z-1490-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
- Manufacturer
- ESAOTE S.P.A.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- UDI 0805604453891
- Serial Numbers: 241700533C
- 241700529C
- 241700607C
- 241700536C
- 241700613C.
Distribution
Distributed nationwide across the United States.
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