ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
Reported: October 15, 2025 Initiated: August 29, 2025 #Z-0038-2026
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.
Details
- Recalling Firm
- ImaCor Inc.
- Units Affected
- 45 units
- Distribution
- US Nationwide distribution in the states of South Carolina, New Jersey, Pennsylvania, Florida, and Georgia.
- Location
- Jericho, NY
Frequently Asked Questions
What product was recalled? ▼
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.. Recalled by ImaCor Inc.. Units affected: 45 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 15, 2025. Severity: Moderate. Recall number: Z-0038-2026.
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