Mint Medical GmbH is recalling mint Lesion software versions 3.9.0 through 3.9.5 and 3.10.0 through 3.10.1. A software malfunction can cause the system to display incorrect orientation labels for certain medical images (DICOM files), which could lead to misinterpretation of patient scans. A total of 83 units were distributed globally, including 20 in the United States, and no injuries have been reported to date.
Incorrect orientation labels on medical images could cause healthcare providers to misidentify the location or side of a patient's findings, potentially leading to errors in diagnosis, staging, or treatment planning.
Software correction or update
Recall #: Z-0709-2025; Quantity: 65 units (13 US, 52 OUS)
Recall #: Z-0710-2025; Quantity: 18 units (7 US, 11 OUS)
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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