ImaCor Inc. recalls ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Mo…

Recall date

September 16, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0231-2025

FDA classification

Class II

Brand / firm

ImaCor Inc.

Sold / distributed

FL ,GA, NJ, TN

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1