FDA Device recall Z-0710-2025
mint Lesion, Software Versions: 3.10.0 and 3.10.1
- FDA Device
- Class II
- ongoing
- Published 2024-12-25
On 2024-12-25 the FDA classified a Class II recall of mint Lesion, Software Versions: 3.10.0 and 3.10.1 by Mint Medical, citing some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0710-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-15 |
| Published | 2024-12-25 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Mint Medical |
| Distribution | US |
Product
mint Lesion, Software Versions: 3.10.0 and 3.10.1.
Reason
Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.
Identifiers
| code_info | Software Versions: 3.10.0 and 3.10.1; UDI-DI: 04260495883106; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0710-2025%22
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