Device product
Functional MR V1.0
Z-0122-2024
Product summary
- Firm
- OLEA MEDICAL
- Event
- Event 93049
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2
- Official record key
device-enforcement:Z-0122-2024
Official wording
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.
Code information: UDI-DI: EOLEFMRIV1P00, Software Versions: V1.0, V1.0 SP1, V1.0 SP2, V1.0 SP3
Distribution pattern: US: MI, MA
Derived failure modes
-
Device software or design
software bug