Home / Recalls / Mint Medical GmbH / Z-0710-2025

Z-0710-2025 Class II Ongoing

Recalled by Mint Medical GmbH — Dossenheim

Recall Details

Product Type: Devices
Report Date: December 25, 2024
Initiation Date: November 15, 2024
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 18 units (7 US, 11 OUS)

Product Description

mint Lesion, Software Versions: 3.10.0 and 3.10.1.

Reason for Recall

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

Distribution Pattern

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.

Code Information

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