FDA Device recall Z-0122-2024
Functional MR V1.0
- FDA Device
- Class II
- ongoing
- Published 2023-10-25
On 2023-10-25 the FDA classified a Class II recall of Functional MR V1.0 by Olea Medical, citing when exporting regions of interest in DICOM SEGMENTATION format, when simultaneously exporting multiple volumes of interest, a functional magnetic resonance software bug may cause….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0122-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-08-10 |
| Published | 2023-10-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Olea Medical |
| Distribution | MA, MI |
Product
Functional MR V1.0
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.
Identifiers
| code_info | UDI-DI: EOLEFMRIV1P00, Software Versions: V1.0, V1.0 SP1, V1.0 SP2, V1.0 SP3 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0122-2024%22
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