Mint Medical GmbH recalls Mint Lesion

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.

Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;

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 outside of working hours). Please verify correctness of the information of prior time-points. Be attentive to potential inconsistencies in lesion attributes when opening existing cases for follow up. Cross check lesion location and categorization with prior radiological reports and image data. If you suspect that the problem may have occurred on your mint Lesion system, please contact Mint Medical support via support@mint-medical.com or any other contact details for technical analysis and investigation. Mint Medical Support will analyze if the malfunction appeared at your mint Lesion system in the past. If you believe that this failure has occurred, please review the potentially affected radiological reports in your reporting application and take the necessary steps to correct them. Pass this notice on to all users of mint Lesion" within your organization. Please maintain awareness of this notice and resulting action for an appropriate period to ensure the effectiveness of the corrective action.

• FDA enforcement recordOfficial FDA database entry for Z-2068-2026
• FDA 510(k) clearance · K142647The device's official FDA premarket clearance record
• FDA device classification · LLZOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.2050The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Mint Medical GmbHSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.