FDA recall Z-0122-2024

OLEA MEDICAL · Class II · device

Product

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

US: MI, MA

Key facts

Status: Ongoing
Initiation date: 2023-08-10
Report date: 2023-10-25
Voluntary/Mandated: Voluntary: Firm initiated
Location: LA CIOTAT, N/A, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0122-2024