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ImaCor Inc. recalls ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultra
Recalled October 15, 2025 · FDA recall Z-0038-2026 · ImaCor
Hazard
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. · FDA Class II
Units
45 units
Sold at
US Nationwide distribution in the states of South Carolina, New Jersey, Pennsylvania, Florida, and Georgia.
Description
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.
Product
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
Manufacturer(s)
ImaCor Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →