Device product
mint Lesion, Software Versions: 3.9.0 through 3.9.5.
Z-0709-2025
Product summary
- Event
- Event 95880
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 65 units (13 US, 52 OUS)
- Official record key
device-enforcement:Z-0709-2025
Official wording
Reason: Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.
Code information: Software Versions: 3.9.0 through 3.9.5; UDI-DI: 04260495880396;
Distribution pattern: 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.
Derived failure modes
-
Device software or design
software versions have a malfunction where they may show incorrect