ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
This recall is currently active, issued October 3, 2025. It was issued by Imacor Inc..
- Company
- Imacor Inc.
- Recall Initiated
- August 29, 2025
- Posted
- October 3, 2025
- Recall Number
- Z-0038-2026
- Quantity
- 45 units
- Firm Location
- Jericho, NY
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of South Carolina, New Jersey, Pennsylvania, Florida, and Georgia.
Lot / Code Info
Model CLT-010; UDI-DI 00861589000108; Lot number: 20261209.
Root Cause
Process control
Action Taken
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.