Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with Recalled by ImaCor Inc. Due to Epoxy used to seal the edge of the...

Date: September 16, 2024
Company: ImaCor Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact ImaCor Inc. directly.

Affected Products

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

Quantity: 73 units

Why Was This 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.

Where Was This Sold?

This product was distributed to 4 states: FL, GA, NJ, TN

Affected (4 states)Not affected

About ImaCor Inc.

ImaCor Inc. has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report