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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

ImaCor Inc.: ClariTEE Ultrasound Probes Recalled Due to Image Quality Risks

Agency Publication Date: October 25, 2024
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Summary

ImaCor Inc. has recalled 73 units of the ClariTEE Probe, a miniature transesophageal echo ultrasound probe used for heart imaging. The recall was initiated because the epoxy used to seal the edge of the transducer exceeded manufacturing specifications, which can weaken the ultrasound signal. This defect may reduce the quality of the diagnostic images obtained during medical procedures, potentially affecting patient care. These probes were distributed to facilities in Florida, Georgia, New Jersey, and Tennessee.

Risk

The excess epoxy can interfere with the ultrasound waves, leading to blurry or poor-quality images. This loss of image clarity could result in a healthcare provider missing critical diagnostic information or misinterpreting a patient's condition during a cardiac examination.

What You Should Do

  1. Identify if you have the affected ClariTEE Probe by checking for model numbers CLT-010 or CLT-010-1.
  2. Verify your specific device by looking for UDI (Unique Device Identifier) 00861589000108 and Lot numbers 20250509 or 20250823.
  3. Immediately contact your healthcare provider or the manufacturer, ImaCor Inc., to determine if your specific probe needs to be returned or replaced.
  4. Medical facilities should sequester any affected probes from their active inventory to prevent further clinical use until instructed otherwise by the manufacturer.
  5. Contact the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA) for additional assistance or to report any adverse events.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification and coordination for affected devices.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: ClariTEE Probe- Miniature transesophageal echo ultrasound probe
Model / REF:
CLT-010
CLT-010-1
UPC Codes:
00861589000108
Lot Numbers:
20250509
20250823

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95459
Status: Active
Manufacturer: ImaCor Inc.
Sold By: ImaCor Inc.
Manufactured In: United States
Units Affected: 73 units
Distributed To: Florida, Georgia, New Jersey, Tennessee

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.