medical Class II Updated 2023-10-25

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

Affected States: MI, MA
Lot/Code Info: UDI-DI: EOLEFMRIV1P00, Software Versions: V1.0, V1.0 SP1, V1.0 SP2, V1.0 SP3
View official government recall

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