Recall Z-0038-2026— ImaCor Inc.

Name: FDA recall Z-0038-2026
Creator: U.S. Food and Drug Administration
Published: 2025-08-29

Class II · Ongoing

Class II FDA medical device recall by ImaCor Inc., initiated 2025-08-29. It names one FDA 510(k) clearance: K220490. Product: ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.. Reason: 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..

Recalling firm: ImaCor Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-08-29
Firm location: Jericho, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K220490 — ImaCor Zura Handheld ZHH-010Imacor, Inc.·cleared 2022-04-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.