Echopixel, Inc. is recalling 9 units of the TRUE 3D VIEWER SYSTEM (Model EP-00001-XX) with software versions 1.0, 1.25, and 1.35. The imaging software may display patient data with an incorrect orientation, which could misrepresent the left, right, top, or bottom sides of the patient. No injuries or incidents have been reported to date. Healthcare providers should contact the manufacturer to address this software orientation issue.
Incorrect image orientation can lead to inaccurate measurements and errors in clinical judgment. This defect could cause a healthcare professional to misidentify anatomical locations during medical procedures or diagnosis.
Quantity 9 systems. Hardware platform includes off-the-shelf stereoscopic display and motion tracking system.
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 · Raw API Response
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