Skip to content

mint Lesion, Software Versions: 3.10.0 and 3.10.1 recallZ-0710-2025 · Mint Medical GmbH · initiated Nov 15, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Mint Medical GmbH or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.

FDA root cause category: Software design

What the company is doing

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.

Recall details

Recall number
Z-0710-2025
Status
Open, Classified
Initiated by the company
Nov 15, 2024
Posted by the FDA
Dec 20, 2024
Recalling firm
Mint Medical GmbH
Quantity
18 units (7 US, 11 OUS)
Product code
LLZ
FDA submissions
K142647
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 description

mint Lesion, Software Versions: 3.10.0 and 3.10.1.

Code information (models, lots, serial numbers)

Software Versions: 3.10.0 and 3.10.1; UDI-DI: 04260495883106;

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

6 devices cleared under K142647 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 95880).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page