LA CIOTAT, N/A, France
OLEA MEDICAL recalls
1 recall recorded since 2018, most recently on 10 August 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 10 August 2023
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0122-2024
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.