Recall Z-0038-2026 ยท ITX Transducer, Ultrasonic, Diagnostic
ImaCor Inc.
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
| Date | Oct 3, 2025 (initiated Aug 29, 2025) |
| Status | Open, Classified |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K220490 | ImaCor Zura Handheld ZHH-010 Imacor, Inc., Apr 8, 2022 |