Mint Medical GmbH recalls mint Lesion, Software Versions: 3.10.0 and 3.10.1.
- Recall date
- November 15, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0710-2025
- FDA classification
- Class II
- Brand / firm
- Mint Medical GmbH
- Sold / distributed
- 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.
Why it was recalled
Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
mint Lesion, Software Versions: 3.10.0 and 3.10.1.
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