Z-0038-2026 Class II Ongoing
FDA device recall Z-0038-2026 was initiated by ImaCor Inc. on August 29, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 45 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 15, 2025
- Initiation Date
- August 29, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45 units
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.
Distribution Pattern
US Nationwide distribution in the states of South Carolina, New Jersey, Pennsylvania, Florida, and Georgia.
Code Information
Model CLT-010; UDI-DI 00861589000108; Lot number: 20261209.