ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound di...
FDA Recall #Z-0231-2025 — Class II — September 16, 2024
Product Description
ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1
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.
Recalling Firm
ImaCor Inc. — Jericho, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
73 units
Distribution
FL ,GA, NJ, TN
Code Information
UDI - Primary - 00861589000108 Lot numbers: 20250509 and 20250823
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated