OLEA MEDICAL recalls Functional MR V1.0

Recall date

August 10, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0122-2024

FDA classification

Class II

Brand / firm

OLEA MEDICAL

Sold / distributed

US: MI, MA

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Functional MR V1.0