Recall Z-0122-2024 ยท LLZ System, Image Processing, Radiological
OLEA MEDICAL
Functional MR V1.0
| Date | Oct 18, 2023 (initiated Aug 10, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| Action | 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 t |
| Quantity | 2 |
| Distribution | US: MI, MA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K221426 | Functional MR V1.0 Olea Medical S.A.S., Jul 6, 2022 |