mint Lesion Software 3.9.0 (Mint Medical) – Orientation Label Error (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
mint Lesion, Software Versions: 3.9.0 through 3.9.5.
Brand
Mint Medical GmbH Friedrich-Ebert-Str. 2 Dossenheim Germany
Lot Codes / Batch Numbers
Software Versions: 3.9.0 through 3.9.5, UDI-DI: 04260495880396
Products Sold
Software Versions: 3.9.0 through 3.9.5; UDI-DI: 04260495880396;
Mint Medical GmbH Friedrich-Ebert-Str. 2 Dossenheim Germany is recalling mint Lesion, Software Versions: 3.9.0 through 3.9.5. due to Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.
Recommended Action
Per FDA guidance
On 11/13/2024 and 11/15/2024 "URGENT FIELD SAFETY NOTICE" letters were emailed to customers. US customers on 11/13/2024 and OUS customers on 11/15/2024. Actions to be taken by the user: Please read this information carefully and assess whether you are using an affected product version and if DICOM series with differing patient orientation may be used in your organization (Note: mint Lesion" shows a notice above the images when multi-frame images are displayed (see Figures 1 and 2). If that is the case, the malfunction may occur in your system. Please be aware that displayed orientation markers may indicate a wrong patient orientation. Verify the patient orientation based on anatomical landmarks that you can see in the images, when you rely on patient orientation for reporting findings (e.g., "anomaly in left kidney"). If possible, do not assess DICOM data that may lead to the malfunction with mint Lesion" . If you suspect that your organization uses DICOM files with the described parameters and that they have already been read using mint Lesion" , you can contact Mint Medical support (support@mint-medical.com) to request analysis of your mint Lesion" instance. If you believe that this failure could have occurred in past use of mint Lesion", please review the potentially affected radiological reports in your reporting application and take the necessary steps to correct them. Please inform Mint Medical if this may have led to any patient harm in your organization. Actions being taken by the manufacturer The error will be corrected with a software update. Mint Medical Support will contact you when the update is available to schedule the installation of the update on your system. If you have any questions, email: incidents@mint-medical.com or call (+49) 6221 32 18018.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026