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...Read More
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