19
Dec
2024

FDA Recall: Software Malfunction May Show Incorrect Label for DICOM Images

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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.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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