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Mint Medical GmbH recalls mint Lesion, Software Versions: 3.9.0 through 3.9.5.
Recalled December 25, 2024 · FDA recall Z-0709-2025 · Mint Medical
Hazard
Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images. · FDA Class II
Units
65 units (13 US, 52 OUS)
Sold at
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.
Description
Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.
Product
mint Lesion, Software Versions: 3.9.0 through 3.9.5.
Manufacturer(s)
Mint Medical GmbH
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →