The Recall Desk
HighFDA (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.

What this means for you

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.

Related recalls

Same category