Day

October 18, 2023
18
Oct

FDA Recall: Software Bug May Cause File Contents Not to Match

October 18, 2023
Company: OLEA MEDICAL Date of Enforcement Report: 10/18/2023 Class II PRODUCT Functional MR V1.0 Recall Number: Z-0122-2024 REASON: 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...
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