Agency classClass IIOur severity:High FDA (Devices)·Z-0710-2025·Announced 2024-12-25

Medical imaging software recall for incorrect DICOM orientation labels

Mint Lesion software versions 3.10.0 and 3.10.1 may display incorrect orientation labels for certain DICOM medical images. The defect affects 18 units distributed across the US and internationally.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm medical device recall with a functional defect (incorrect image orientation labeling) that could impact clinical decision-making. No injuries or adverse events have been reported. As a Class II medical device recall without hospitalization reports, it meets the criteria for Score 3 (High): risk-of-harm products where injury has not yet been reported.

Plain-English summary

Mint Lesion software versions 3.10.0 and 3.10.1 is subject to a Class II recall due to a software malfunction that may display incorrect orientation labels for a specific subset of DICOM medical images. Incorrect image orientation labeling could impact proper interpretation of radiological imaging studies.

The affected software has been distributed to 18 units worldwide: 7 units in the United States (Arkansas, California, Florida, Georgia, Michigan, Minnesota, New York, Ohio, Pennsylvania, Tennessee, Texas, and Wisconsin) and 11 units internationally (Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Switzerland, and the United Kingdom).

Users of mint Lesion software versions 3.10.0 and 3.10.1 should contact Mint Medical GmbH regarding available software updates or corrections. Healthcare facilities using these software versions should review workflows and consider verification procedures for image orientation to ensure proper clinical interpretation.

The recalled product

Product: mint Lesion, Software Versions: 3.10.0 and 3.10.1.
Manufacturer: Mint Medical GmbH
Category: Medical Device — Medical Imaging Software
Hazard: mis-labeling
software-malfunction

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Software Versions: 3.10.0 and 3.10.1
UDI-DI: 04260495883106

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Mint Medical GmbH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Mint Medical GmbH

See all →

High
Mint Lesion Software Data Loss During Server Connection Interruption
FDA (Devices) · 2026-05-13
High
Medical Imaging Software Recall: mint Lesion Orientation Display Malfunction
FDA (Devices) · 2024-12-25

Same hazard · mis labeling