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Open, Classified

ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.

FDA Recall Z-0038-2026 · Posted 2025-10-03

Recalling FirmImaCor Inc.
Recall StatusOpen, Classified
Product CodeITX
Date Initiated2025-08-29
Product Quantity45 units

Reason for Recall

Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa.

Firm Action

ImaCor, Inc. notified consignees on 08/29/2025 via email. Consignees were instructed to Immediately discontinue use of the affected ClariTEE probes, quarantine all affected units in inventory, confirm receipt of this notice, return all affected units to ImaCor, and complete and return the response form.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the states of South Carolina, New Jersey, Pennsylvania, Florida, and Georgia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K220490ImaCor Zura Handheld ZHH-010Imacor, Inc. · 2022-04-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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