FDA DeviceClass IINotable

FDA Recall: Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;

Date: 2026-05-13
Brand: Mint Medical GmbH
Category: Medical Device
FDA Class: Class II

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.

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.

Remedy

101 systems

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