FDASeptember 16, 2024device
ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
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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