Company: OLEA MEDICAL
Date of Enforcement Report: 10/18/2023
Class II
PRODUCT
Functional MR V1.0
Recall Number:
Z-0122-2024
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/MANUFACTURER:
OLEA MEDICAL
VOLUME OF PRODUCT IN COMMERCE:
2
DISTRIBUTION:
US: MI, MA
