# FDA recall Z-0709-2025

> **Mint Medical GmbH** · Class II · device recall initiated 2024-11-15.

## Product

mint Lesion, Software Versions: 3.9.0 through 3.9.5.

## Reason for recall

Some software versions have a malfunction  where they may show incorrect orientation labels for a specific subset of DICOM images.

## Distribution

Worldwide distribution: US (nationwide): AR, CA, FL, GA, MI, MN, NY, OH, PA, TN, TX, WI; and OUS (International) to countries of: Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom.

## Key facts

- **Recall number:** Z-0709-2025
- **Recalling firm:** Mint Medical GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-15
- **Report date:** 2024-12-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dossenheim, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0709-2025

## Citation

> AI Analytics. FDA recall Z-0709-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0709-2025. Source: US FDA. Licensed CC0.

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