FDA Medical Device Recalls (openFDA)
ImaCor Inc.: ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
- Recall number
- Z-0038-2026
- Recalling firm
- ImaCor Inc.
- Product
- ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
- Status
- Open, Classified
- Initiated
- 2025-08-29
- Posted
- 2025-10-03
- Terminated
- not on file
- Reason
- Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa.
- Root cause
- Process control
- Action
- ImaCor, Inc. notified consignees on 08/29/2025 via email. Consignees were instructed to Immediately discontinue use of the affected ClariTEE probes, quarantine all affected units in inventory, confirm receipt of this notice, return all affected units to ImaCor, and complete and return the response form.
- Quantity
- 45 units
- Distribution
- US Nationwide distribution in the states of South Carolina, New Jersey, Pennsylvania, Florida, and Georgia.
- Lot, serial or model codes
- Model CLT-010; UDI-DI 00861589000108; Lot number: 20261209.
- 510(k) numbers
- ["K220490"]
- PMA numbers
- not on file
- Product code
- ITX
- Firm FEI
- 3006382185
- Firm city
- Jericho
- Firm state
- NY
- Firm country
- not on file
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