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Recall Observatory FDA recall evidence

Device product

mint Lesion, Software Versions: 3.9.0 through 3.9.5.

Z-0709-2025

November 15, 2024

Class II

Product summary

Firm
Mint Medical GmbH
Event
Event 95880
Status
Ongoing
Classification
Class II
Quantity
65 units (13 US, 52 OUS)
Official record key
device-enforcement:Z-0709-2025

Official wording

Reason: Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.

Code information: Software Versions: 3.9.0 through 3.9.5; UDI-DI: 04260495880396;

Distribution pattern: Worldwide distribution: US (nationwide): AR, CA, FL, GA, MI, MN, NY, OH, PA, TN, TX, WI; and OUS (International) to countries of: Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software versions have a malfunction where they may show incorrect