Recall Z-2068-2026 ยท LLZ System, Image Processing, Radiological
Mint Medical GmbH
Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
| Date | May 6, 2026 (initiated Jan 7, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | On or about January 7, 2026 Urgent Field Safety Notice letters were emailed to customers. Customers were instructed to read the notice and check if any affected product is available for use. If that is the case, the malfunction may have occurred and may occur in your system. Please be aware that the malfunction may occur. Your IT department must ensure that no temporary network interruptions occur in your clinical network. Also, your IT department must ensure that the mint Lesion server is not restarted while users work with mint Lesion application (i.e., the server may be restartet, but only |
| Quantity | 101 systems |
| Distribution | Worldwide distribution - US Nationwide and the countries of Germany, Switzerland, Austria, Belgium, Italy, France, Romania, Netherlands, United Kingdom, Spain, Czech Republic, Ireland, Poland; |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142647 | mint Lesion Mint Medical GmbH, Apr 13, 2015 |