Agency classClass IIOur severity:High FDA (Devices)·Z-0709-2025·Announced 2024-12-25

Medical Imaging Software Recall: mint Lesion Orientation Display Malfunction

Mint Medical is recalling mint Lesion software versions 3.9.0–3.9.5 due to a malfunction that may display incorrect orientation labels for certain medical images. 65 units were distributed in 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: FDA Class II medical device software with a display malfunction affecting diagnostic image interpretation. No illnesses or injuries reported, but incorrect orientation labels constitute a risk-of-harm in medical imaging where diagnostic accuracy is critical.

Plain-English summary

Mint Medical GmbH is recalling mint Lesion software versions 3.9.0 through 3.9.5. The software is used for medical image analysis.

The recall is issued because the software may display incorrect orientation labels for a specific subset of DICOM images. DICOM (Digital Imaging and Communications in Medicine) is a standard format for medical images.

65 units of the affected software versions were distributed globally. In the United States, units were distributed to Arkansas, California, Florida, Georgia, Michigan, Minnesota, New York, Ohio, Pennsylvania, Tennessee, Texas, and Wisconsin. Additional units were distributed internationally to Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Switzerland, and the United Kingdom.

Customers who have received affected software should contact Mint Medical GmbH for guidance on remediation or software updates.

The recalled product

Product: mint Lesion, Software Versions: 3.9.0 through 3.9.5.
Manufacturer: Mint Medical GmbH
Category: Medical Device — Medical Imaging Software
Hazard: mis-labeling
display-error

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: 3.9.0 through 3.9.5
UDI-DI: 04260495880396

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 for incorrect DICOM orientation labels
FDA (Devices) · 2024-12-25

Same hazard · mis labeling