Esaote endocavity ultrasound probe recalled because liquid may leak in
Esaote is recalling five Endocavity ultrasonic probes, model E 3-12, because a potential weakness in the probe body may allow liquid to leak from the casing near the cable.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: a breach in the casing of a probe used inside the body is a hazard, and no injuries are stated in the source.
Plain-English summary
ESAOTE S.P.A. is recalling the Esaote Endocavity ultrasonic probe, model E 3-12, REF 120000038. About 5 units were distributed in North Carolina and Texas. The FDA has classified this recall as Class II.
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.
Affected product carries UDI 0805604453891 and serial numbers 241700533C, 241700529C, 241700607C, 241700536C and 241700613C.
Facilities can identify affected probes by the model, UDI and serial numbers above, and may contact ESAOTE S.P.A. for further information.
The recalled product
- Product
- Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
- Manufacturer
- ESAOTE S.P.A.
- Category
- Medical Device — Ultrasound
- Affected units
- 5
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
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