Reported Oct 25, 2023 · Ongoing
Functional MR V1.0
Olea Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: OLEA MEDICAL · 93 AVANUE DU SORBIER, · LA CIOTAT, N/A · N/A
Is this the product you have?
- Functional MR V1.0
- Lot codes and dates
- UDI-DIEOLEFMRIV1P00
- Software Versions
V1.0V1.0 SP1V1.0 SP2V1.0 SP3
- Amount recalled
- 2
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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