Drug recall
mint Lesion, Software Versions: 3.10.0 and 3.10.1.
FDA recall event 95880 · Class II · Mint Medical GmbH
Key facts
| Event ID | 95880 |
|---|---|
| Recall numbers | Z-0709-2025, Z-0710-2025 |
| Recalling firm | Mint Medical GmbH |
| Product type | Devices |
| Products | mint Lesion, Software Versions: 3.10.0 and 3.10.1., mint Lesion, Software Versions: 3.9.0 through 3.9.5. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images. |
| Initiation date | Nov 15, 2024 |
| Report date | Dec 25, 2024 |
| City | Dossenheim |
| Country | Germany |
| FEI number | 3011706018 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: