Class II

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

ImaCor Inc. · September 16, 2024

Reason for Recall

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.

Distribution

FL ,GA, NJ, TN

States Affected

FL, GA, NJ, TN

Quantity Affected

73 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0231-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

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