Z-0709-2025Class II

mint Lesion, Software Versions: 3.9.0 through 3.9.5

Name: Z-0709-2025 mint Lesion, Software Versions: 3.9.0 through 3.9.5
Creator: Mint Medical GmbH
Published: 2024-11-15
License: https://open.fda.gov/license/

Mint Medical GmbH / initiated 2024-11-15 / Open, Classified / root cause: software

FDA source

Mint Medical GmbH began a recall of mint Lesion, Software Versions: 3.9.0 through 3.9.5 on 2024-11-15. FDA classified it as Class II and gives the reason as "Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0709-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-15
Posted: 2024-12-20
Recalling firm: Mint Medical GmbH
Product: mint Lesion, Software Versions: 3.9.0 through 3.9.5.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.
Root cause tag: software
FDA 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 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 ([email protected]) 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: [email protected] or call (+49) 6221 32 18018.
Quantity in commerce: 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.
Product codes and lots: Software Versions: 3.9.0 through 3.9.5; UDI-DI: 04260495880396;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0709-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0709-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-25	2024-12-19
Z-0710-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-25	2024-12-19

Product code LLZ

K142647Class IImint LesionMint Medical GmbH / cleared 2015-04-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)