Class 2 Device Recall mint Lesion

• Date Initiated by Firm: November 15, 2024
• Date Posted: December 20, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0710-2025
• Recall Event ID: 95880
• 510(K)Number: K142647
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: mint Lesion, Software Versions: 3.10.0 and 3.10.1.
• Code Information: Software Versions: 3.10.0 and 3.10.1; UDI-DI: 04260495883106
• Recalling Firm/ Manufacturer: Mint Medical GmbH; Friedrich-Ebert-Str. 2; Dossenheim Germany
• For Additional Information Contact: Dr. Jochen Neuhaus; 49-6221-3218018
• Manufacturer Reason for Recall: Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.
• FDA Determined Cause: Software design
• Action: 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.
• Quantity in Commerce: 18 units (7 US, 11 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LLZ