Device product
Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
Z-2068-2026
Product summary
- Event
- Event 98753
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 101 systems
- Official record key
device-enforcement:Z-2068-2026
Official wording
Reason: If the connection between a mint Lesion workstation and the mint Lesion server is interrupted while performing a read, in rare cases some information may be lost or incorrectly linked to other patients.
Code information: Software Versions: 3.4.0 up to 3.9.5. UDI-DI: 04260495880341, 04260495880358, 04260495880365, 04260495880372, 04260495880389, 04260495880396.
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Germany, Switzerland, Austria, Belgium, Italy, France, Romania, Netherlands, United Kingdom, Spain, Czech Republic, Ireland, Poland;
Derived failure modes
-
Unknown
If the connection between a mint Lesion workstation and the mint Lesion server is interrupted while performing a read, in rare cases some information may be lost or incorrectly linked to other patients.