Echopixel, Inc. is recalling 18 units of its True 3D Viewer software (Model EP-00003) because a defect can cause medical images to display in the wrong orientation. This issue specifically occurs when importing enhanced ultrasound data used for clinical review and pre-operative surgical planning. To date, there have been no reports of injuries or incidents related to this software defect.
If a medical image is displayed in the wrong orientation, it could lead to an incorrect diagnosis or a flawed surgical treatment plan, potentially causing serious harm to patients during surgery.
Includes full release and research/develop versions.
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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