Olea Medical has recalled two units of its Functional MR V1.0 software, including versions V1.0 through V1.0 SP3, because of a software bug. When a user tries to export multiple regions of interest at the same time in a specific format, the file contents may not match their descriptions. This defect can cause clinicians to misinterpret the magnetic resonance data when making medical decisions. Affected units were distributed in Michigan and Massachusetts.
The software bug causes medical imaging data to be mislabeled during the export process. This could lead a healthcare provider to misidentify specific areas of interest in a patient's scan, potentially resulting in an incorrect diagnosis or improper treatment plan.
Manufacturer Notification and Guidance
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.
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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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