---
title: "Functional MR V1.0 — FDA record Z-0122-2024 | Is It on Recall"
description: "When exporting regions of interest in DICOM SEGMENTATION format, when simultaneously exporting multiple volumes of interest, a functional magnetic resonance sof"
url: https://isitonrecall.com/recall/fda-device-z-0122-2024-functional-mr-v1-0/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Functional MR V1.0 — FDA record Z-0122-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Aug 10, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Functional MR V1.0
- **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.
- **Classification**: Class II
- **Recalling firm**: OLEA MEDICAL
- **Quantity**: 2
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0122-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0122-2024%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI-DI: EOLEFMRIV1P00, Software Versions: V1.0, V1.0 SP1, V1.0 SP2, V1.0 SP3 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

US: MI, MA

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Massachusetts](https://isitonrecall.com/state/massachusetts/)
- [Michigan](https://isitonrecall.com/state/michigan/)

## Dates in the source

- **Report date**: Oct 25, 2023
- **Recall initiation date**: Aug 10, 2023
- **Center classification date**: Oct 18, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0122-2024%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [OLEA MEDICAL records](https://isitonrecall.com/brand/olea-medical/)