OLEA MEDICAL recalls Functional MR V1.0
Recalled Product
Functional MR V1.0
Hazard / Issue
When exporting regions of interest in DICOM SEGMENTATION format, when simultaneously exporting multiple volumes of interest, a functional magnetic resonance software bug may cause file contents and associated series descriptions to not match, which could lead to a misinterpretation of clinical data.
Issued by
FDA
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