ClariTEE Probe- Miniature transesophageal echo ultrasound… recallZ-0231-2025 · ImaCor Inc. · initiated Sep 16, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ImaCor Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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 shipping cost. Ship to: ImaCor Inc, 50 Jericho Turnpike, Suite 105, Jericho, NY 11753. Destination phone number is (516) 393-0970. o Attach a copy of this letter inside the package for reference. 4. Replacement Devices o Once we receive the returned devices, we will ship replacement probes to your facility. Replacement probes are expected to be available on or about October 15, 2024. Please return all affected devices by October 7. If you have any questions or need assistance, please contact Jenn Kujawski at [email protected]. Our team is ready to assist you with any inquiries and can provide additional details if needed.
Recall details
- Recall number
- Z-0231-2025
- Status
- Open, Classified
- Initiated by the company
- Sep 16, 2024
- Posted by the FDA
- Oct 25, 2024
- Recalling firm
- ImaCor Inc.
- Quantity
- 73 units
- Product code
- ITX
- FDA submissions
- K220490, K080223, K100989, K142054
- Distribution
- FL ,GA, NJ, TN
Product description
ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1
Code information (models, lots, serial numbers)
UDI - Primary - 00861589000108 Lot numbers: 20250509 and 20250823
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ClariTEEImacor Inc · Transducer, Ultrasonic, Diagnostic2 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page