ImaCor Inc. is recalling 45 units of the ClariTEE Miniaturized TEE probe (Model CLT-010) due to a manufacturing error that causes the device's tip to move in the opposite direction of the control lever. During medical procedures, moving the lever forward causes the tip to tilt forward when it should tilt backward, and vice versa. Healthcare providers should stop using affected units and contact the manufacturer to arrange for a replacement or repair.
The reversed movement of the probe tip can lead to incorrect placement or accidental tissue damage during ultrasound procedures. This defect poses a risk of internal injury if a clinician unintentionally steers the probe against delicate structures while believing they are moving it away.
Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
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.
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
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