Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Functional MR V1.0 Recalled by OLEA MEDICAL Due to When exporting regions of interest in DICOM SEGMENTATION...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact OLEA MEDICAL directly.
Affected Products
Functional MR V1.0
Quantity: 2
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 2 states: MA, MI
About OLEA MEDICAL
OLEA MEDICAL has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report