Mint Medical recalls software versions 3.9.0-3.9.5 of Mint Lesion due to potential incorrect DICOM image orientation labels. Affected users should check their software version and contact Mint Medical for details.
Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.
Mint Medical is recalling software versions 3.9.0 through 3.9.5 of its Mint Lesion product because they may show incorrect orientation labels for certain DICOM images. This could lead to misinterpretation of medical images, but the recall does not involve immediate safety risks.
The software may display incorrect orientation labels for specific DICOM images. This could cause medical professionals to misinterpret the images, potentially leading to incorrect clinical decisions. However, the issue does not involve physical harm or immediate safety risks.
Users of Mint Lesion software versions 3.9.0 through 3.9.5 are affected. Medical professionals who rely on these software versions for imaging analysis may be at risk of misinterpreting DICOM images.
Check if your Mint Lesion software version is 3.9.0 through 3.9.5. The recall includes software versions 3.9.0 through 3.9.5 with UDI-DI: 04260495880396.
Determine your Mint Lesion software version to see if it is 3.9.0 through 3.9.5.
Yes, if you use Mint Lesion software versions 3.9.0 through 3.9.5, this recall applies.
Contact Mint Medical for details on how to update or address the issue.
No, the recall does not involve physical safety risks; it is a potential mislabeling issue.
We’ve drafted a message you can send Mint Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0709-2025 — Mint Medical Mint Medical Hello, I own a Mint Medical that is covered by recall Z-0709-2025 from Mint Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
