FDA-Device2024-12-25Class II
mint Lesion, Software Versions: 3.10.0 and 3.10.1.
Mint Medical GmbH
Hazard
Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.
Sold states
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.
Affected count
18 units (7 US, 11 OUS)
Manufactured in
Friedrich-Ebert-Str. 2, Dossenheim, Germany
Products
mint Lesion, Software Versions: 3.10.0 and 3.10.1.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0710-2025Don't want to check this manually?
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