OLEA MEDICAL recalls Functional MR V1.0 software versions V1.0 to V1.0 SP3 due to a bug that may cause clinical data misinterpretation when exporting multiple DICOM segmentation volumes.
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.
OLEA MEDICAL is recalling its Functional MR software versions V1.0 through V1.0 SP3. This software bug can cause clinical data to be misinterpreted when exporting multiple volumes of interest in DICOM segmentation format, potentially affecting medical decisions.
The software bug occurs when exporting multiple volumes of interest in DICOM segmentation format. This can cause the exported file contents and series descriptions to not match, leading to incorrect clinical data interpretation. While this may cause confusion, it does not pose a direct physical risk to users.
Users of OLEA MEDICAL's Functional MR software versions V1.0 to V1.0 SP3 are affected. Medical professionals who rely on this software for MRI data analysis are most at risk of misinterpreting clinical results.
Check if you have OLEA MEDICAL's Functional MR software versions V1.0, V1.0 SP1, V1.0 SP2, or V1.0 SP3. The software uses a unique identifier EOLEFMRIV1P00.
Install the latest software update to fix the bug. The current versions V1.0 to V1.0 SP3 are affected.
No, this software bug does not cause physical harm but may lead to misinterpreted clinical data when exporting multiple volumes of interest.
Check your software version in the product description: V1.0, V1.0 SP1, V1.0 SP2, or V1.0 SP3 with unique identifier EOLEFMRIV1P00.
Update to the latest software version to fix the bug. The current versions V1.0 to V1.0 SP3 are affected.
We’ve drafted a message you can send OLEA MEDICAL to request your refund or repair — edit it as you like.
Subject: Recall Z-0122-2024 — OLEA MEDICAL OLEA MEDICAL Hello, I own a OLEA MEDICAL that is covered by recall Z-0122-2024 from OLEA MEDICAL. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
