FDA Medical Device Recalls (openFDA)
ESAOTE S.P.A.: Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
- Recall number
- Z-1490-2026
- Recalling firm
- ESAOTE S.P.A.
- Product
- Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
- Status
- Completed
- Initiated
- 2025-03-14
- Posted
- 2026-03-03
- Terminated
- not on file
- 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.
- Root cause
- Process control
- Action
- Esaote issued a Field Safety Notice to its consignees on 3/14/2025 via FedEx. The notice explained the problem with the device, potential risk of use and requested the following: "Actions to be performed by the user " If the operator detects the issue during the inspection, they must NOT use the probe and should contact Esaote's technical support. " Please distribute this Safety Notice to all personnel involved within your organization and to all users of the device. " If the device is no longer in your possession, please provide Esaote with the new owner's details or inform us about the current status of the device. As a precautionary measure, and to complete the root cause analysis while improving our processes and customer service, Esaote will proceed with a voluntary precautionary recall. Our Technical Support Service will soon contact customers who own the affected units to arrange for the replacement of the probe."
- Quantity
- 5 units
- Distribution
- US: Nationwide distribution in the states of NC and TX.
- Lot, serial or model codes
- UDI 0805604453891, Serial Numbers: 241700533C, 241700529C, 241700607C, 241700536C, 241700613C.
- 510(k) numbers
- ["K230179"]
- PMA numbers
- not on file
- Product code
- ITX
- Firm FEI
- 3012981490
- Firm city
- Sesto Fiorentino
- Firm state
- not on file
- Firm country
- Italy
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28