FDAHealthAugust 29, 2025
ImaCor Inc. — ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 29, 2025
US Nationwide distribution in the states of South Carolina, New Jersey, Pennsylvania, Florida, and Georgia.
What's affected?
- Product
- ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
- Brand
- ImaCor Inc.
- Lot code
- 20261209
Additional details
Model CLT-010; UDI-DI 00861589000108; Lot number: 20261209.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 45 units.
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