Z-0231-2025Class II

ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic...

Name: Z-0231-2025 ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic...
Creator: ImaCor Inc.
Published: 2024-09-16
License: https://open.fda.gov/license/

IMACOR, Inc / initiated 2024-09-16 / Open, Classified / root cause: manufacturing process

FDA source

ImaCor Inc. began a recall of ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1 on 2024-09-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0231-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-16
Posted: 2024-10-25
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
Product code: ITX Transducer, Ultrasonic, Diagnostic
Reason for recall: 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 tag: manufacturing process
FDA 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 [email protected]. Our team is ready to assist you with any inquiries and can provide additional details if needed.
Quantity in commerce: 73 units
Distribution: FL ,GA, NJ, TN
Product codes and lots: UDI - Primary - 00861589000108 Lot numbers: 20250509 and 20250823

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0231-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0231-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-06	2024-10-25

Product code ITX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)