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OLEA MEDICAL recalls Functional MR V1.0
Recalled October 25, 2023 · FDA recall Z-0122-2024 · OLEA MEDICAL
Hazard
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. · FDA Class II
Units
2
Sold at
US: MI, MA
Description
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.
Product
Functional MR V1.0
Manufacturer(s)
OLEA MEDICAL
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →