Official recall record
Functional MR V1.0
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-08-10
- Country of alert
- France
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- OLEA MEDICAL
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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