Functional MR V1.0 recall: Software Issue
Functional MR V1.0
Why was Functional MR V1.0 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: EOLEFMRIV1P00, Software Versions: V1.0, V1.0 SP1, V1.0 SP2, V1.0 SP3
- Product
- Functional MR V1.0
- Recalling firm
- OLEA MEDICAL
- Quantity
- 2
- Distribution
- US: MI, MA
- Recall date
- October 25, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)