ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe fo...
FDA Recall #Z-0038-2026 — Class II — August 29, 2025
Product Description
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
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.
Recalling Firm
ImaCor Inc. — Jericho, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
45 units
Distribution
US Nationwide distribution in the states of South Carolina, New Jersey, Pennsylvania, Florida, and Georgia.
Code Information
Model CLT-010; UDI-DI 00861589000108; Lot number: 20261209.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated