Company: Mint Medical GmbH
Date of Enforcement Report: 12/19/2024
Class: II
PRODUCT:
mint Lesion, Software Versions: 3.9.0 through 3.9.5
Recall Number:
Z-0709-2025
REASON:
Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.
RECALLING FIRM/MANUFACTURER:
Mint Medical GmbH
VOLUME OF PRODUCT IN COMMERCE:
65 units (13 US, 52 OUS)
DISTRIBUTION:
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.
