Z-0122-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 25, 2023
- Initiation Date
- August 10, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
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.
Distribution Pattern
US: MI, MA
Code Information
UDI-DI: EOLEFMRIV1P00, Software Versions: V1.0, V1.0 SP1, V1.0 SP2, V1.0 SP3