# FDA recall Z-0122-2024

> **OLEA MEDICAL** · Class II · device recall initiated 2023-08-10.

## 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

- **Recall number:** Z-0122-2024
- **Recalling firm:** OLEA MEDICAL
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0122-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0122-2024. Source: US FDA. Licensed CC0.

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