The Recall Desk

FDA (Devices) recall action 95880

Mint Medical GmbH recalled 2 products on 2024-12-25

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2024-12-25
Critical
0
Units
—

Why these products were recalled

Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··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.

    Product
    mint Lesion, Software Versions: 3.9.0 through 3.9.5.
    Category
    Distribution
    12 states
  • HighFDA (Devices)··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.

    Product
    mint Lesion, Software Versions: 3.10.0 and 3.10.1.
    Category
    Distribution
    12 states