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.
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: 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
- 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.
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