Recall Z-0122-2024— OLEA MEDICAL
Class II · Ongoing
Class II FDA medical device recall by OLEA MEDICAL, initiated 2023-08-10. It names one FDA 510(k) clearance: K221426. 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..
- Recalling firm
- OLEA MEDICAL
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-08-10
- Firm location
- LA CIOTAT, N/A, France
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.