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

FDA device recall Z-2068-2026 · posted 2026-05-06 · Open, Classified

Recall details

Recalling firm

Mint Medical GmbH

Reason for recall

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LLZ

Quantity affected

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;

Date initiated

2026-01-07

Date posted

2026-05-06

Location

Dossenheim, Germany

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