mint Lesion, Software Versions: 3.9.0 through 3.9.5.

FDA device recall Z-0709-2025 · posted 2024-12-20 · Open, Classified

Recall details

Recalling firm

Mint Medical GmbH

Reason for recall

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

Action taken

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.

Root cause

Software design

Status

Open, Classified

Product code

LLZ

Quantity affected

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, Switzerl

Date initiated

2024-11-15

Date posted

2024-12-20

Location

Dossenheim, Germany

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