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Recall Observatory FDA recall evidence

Device product

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

Z-2068-2026

January 07, 2026

Class II

Product summary

Firm
Mint Medical GmbH
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

    reason.no_named_rule · v1.0.0

    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.