FDA-Device2025-10-15Class II
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
ImaCor Inc.
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.
Sold states
US Nationwide distribution in the states of South Carolina, New Jersey, Pennsylvania, Florida, and Georgia.
Affected count
45 units
Manufactured in
50 Jericho Tpke Ste 105, Jericho, NY, United States
Products
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0038-2026Don't want to check this manually?
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