Class II

Medical Device Recall: mint Lesion, Software Versions: 3.10.0 and 3.10.1.

Mint Medical GmbH · November 15, 2024

Reason for Recall

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

Distribution

Worldwide distribution: US (nationwide): AR, CA, FL, GA, MI, MN, NY, OH, PA, TN, TX, WI; and OUS (International) to countries of: Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom.

States Affected

NATIONWIDE

Quantity Affected

18 units (7 US, 11 OUS)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0710-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.