Functional MR V1.0
FDA device recall Z-0122-2024 · posted 2023-10-18 · Open, Classified
Recall details
- Recalling firm
- OLEA MEDICAL
- 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.
- Action taken
- On 8/10/23, field safety notices were emailed to customers who were told to take the following actions: Advice for the user to detect if the bug occurred: This defect can be detected within the Functional MR V1.0 user interface by displaying the exported volume on an anatomical sequence. To detect the issue, the VOI shall be dragged and dropped from the data browser on an anatomical sequence, which will display a notification, indicating the original VOI s name. Outside of Functional MR V1.0 user interface, the user may check the DICOM tag "Segment Label (0062,0003)" in the viewer used, as this DICOM tag contains the correct VOI s name. Workaround: This problem can be overcome when exporting VOIs individually and has no impact on exporting VOIs merged with an anatomical map. New software will be available in October 2023. Complete and return the reply form via email to qa-ra@olea-medical.com
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- LLZ
- Quantity affected
- 2
- Distribution
- US: MI, MA
- Date initiated
- 2023-08-10
- Date posted
- 2023-10-18
- Location
- LA CIOTAT, France
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Functional MR V1.0 (K221426) | Olea Medical S.A.S. | 2022-07-06 |