18
Oct
2023

FDA Recall: Software Bug May Cause File Contents Not to Match

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0

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

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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