ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.

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.

Code information: Model CLT-010; UDI-DI 00861589000108; Lot number: 20261209.

Distribution pattern: US Nationwide distribution in the states of South Carolina, New Jersey, Pennsylvania, Florida, and Georgia.