Recall Z-0709-2025 ยท LLZ System, Image Processing, Radiological
Mint Medical GmbH
mint Lesion, Software Versions: 3.9.0 through 3.9.5.
| Date | Dec 20, 2024 (initiated Nov 15, 2024) |
| Status | Open, Classified |
| Reason | Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images. |
| Root 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142647 | mint Lesion Mint Medical GmbH, Apr 13, 2015 |