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.
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-0038-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.