Official recall notice
FDA DeviceClass IINotable
FDA Recall: Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
- Recall date
- 2026-05-13
- Brand
- Mint Medical GmbH
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
If the connection between a mint Lesion workstation and the mint Lesion server is interrupted while performing a read, in rare cases some information may be lost or incorrectly linked to other patients.
Recommended action
What to do
101 systems
Product description
If the connection between a mint Lesion workstation and the mint Lesion server is interrupted while performing a read, in rare cases some information may be lost or incorrectly linked to other patients.