Functional MR V1 — Class II medical device recall Z-0122-2024
Ongoing recall by OLEA MEDICAL, reported 2023-10-25, distributed in MA, MI. When exporting regions of interest in DICOM SEGMENTATION format, when simultaneously exporting multiple volume
| Recall number | Z-0122-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | OLEA MEDICAL, LA CIOTAT, N/A, France |
| Recall initiated | 2023-08-10 |
| Classified | 2023-10-18 |
| Reported by FDA | 2023-10-25 |
| Distributed | MA, MI |
| Quantity | 2 |
| Reason classes | software |
Product
Functional MR V1.0
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0122-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.