FDA Medical Device Recalls (openFDA)
ImaCor Inc.: ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1
- Recall number
- Z-0231-2025
- Recalling firm
- ImaCor Inc.
- Product
- ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1
- Status
- Open, Classified
- Initiated
- 2024-09-16
- Posted
- 2024-10-25
- Terminated
- not on file
- 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 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 jenn@imacorinc.com. Our team is ready to assist you with any inquiries and can provide additional details if needed.
- Quantity
- 73 units
- Distribution
- FL ,GA, NJ, TN
- Lot, serial or model codes
- UDI - Primary - 00861589000108 Lot numbers: 20250509 and 20250823
- 510(k) numbers
- ["K220490","K080223","K100989","K142054"]
- PMA numbers
- not on file
- Product code
- ITX
- Firm FEI
- 3006382185
- Firm city
- Jericho
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28