FDA-Device2024-11-06Class II
ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1
ImaCor Inc.
Hazard
Epoxy used to seal the edge of the transducer into its paddle exceeded specification. This variability could attenuate the ultrasound signal with a potential impact on the quality of images obtained from the probes.
Sold states
FL ,GA, NJ, TN
Affected count
73 units
Manufactured in
50 Jericho Tpke Ste 105, N/A, Jericho, NY, United States
Products
ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0231-2025Don't want to check this manually?
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