Class II — OLEA MEDICAL
| Recalling firm | Olea Medical S.A.S. |
|---|---|
| Registered facility | OLEA MEDICAL (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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 a misinterpretation of clinical data. |
| Product | Functional MR V1.0 |
| Quantity | 2 |
| Distribution | US: MI, MA |
| Initiated | 2023-08-10 |
| Classified | 2023-10-18 |
| Recall number | Z-0122-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — OLEA MEDICAL (Z-0122-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93049/
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