Recall Z-0231-2025 ยท ITX Transducer, Ultrasonic, Diagnostic
ImaCor Inc.
ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1
| Date | Oct 25, 2024 (initiated Sep 16, 2024) |
| Status | Open, Classified |
| Reason | Epoxy used to seal the edge of the transducer into its paddle exceeded specification. This variability could attenuate the ultrasound signal with a potential impact on the quality of images obtained from the probes. |
| Root cause | Process control |
| Action | ImaCor issued Inventory Correction for ImaCor ClariTEE Probe (CLT-010 and CLT-010-1) letter on 9/16/24. Letter states reason for recall, health risk and action to take: 1. Identify the Affected Devices o Please check your inventory for ClariTEE probes with lot numbers 20250509 and 20250823. Inform ImaCor of the number of applicable probes currently in inventory. 2. Prepare the Products for Return o Package the affected products securely to prevent damage during shipment. 3. Shipping Instructions o Please ship the affected products via FedEx using FedEx Account Number 665380920 to cover the shi |
| Quantity | 73 units |
| Distribution | FL ,GA, NJ, TN |
| FDA record | Open on fda.gov |