FDAAugust 29, 2025device
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
imacor
UPCs
00861589000108
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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