Dermasensor Inc. is recalling 343 units (of which 9 specific units are affected) of the DermaSensor (Model 10101, Software Version 3.0.2), a diagnostic device used by doctors to examine suspicious skin lesions. The recall was issued because the device may not meet its technical specifications, which can lead to incorrect results. Physicians are advised to contact the manufacturer to arrange for a return or correction of the device.
The device may provide inaccurate readings, potentially leading to a delay in referring patients for medical care or resulting in an incorrect assessment of lesions suspicious for skin cancer.
Software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer.
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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