Functional MR V1.0
Reported: October 25, 2023 Initiated: August 10, 2023 #Z-0122-2024
Product Description
Functional MR V1.0
Reason for Recall
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.
Details
- Recalling Firm
- OLEA MEDICAL
- Units Affected
- 2
- Distribution
- US: MI, MA
- Location
- LA CIOTAT, N/A
Frequently Asked Questions
What product was recalled? ▼
Functional MR V1.0. Recalled by OLEA MEDICAL. Units affected: 2.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 25, 2023. Severity: Moderate. Recall number: Z-0122-2024.
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