FDA Enforcement
Class II
Ongoing
mint Lesion, Software Versions: 3.9.0 through 3.9.5.
Recall: Z-0709-2025
·
Reported December 25, 2024
Enforcement
- Recall Number
- Z-0709-2025
- Event ID
- 95880
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Mint Medical GmbH
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- December 25, 2024
- Initiation Date
- November 15, 2024
- Classification Date
- December 19, 2024
- Address
- Friedrich-Ebert-Str. 2, Dossenheim, N/A, Germany
Description
mint Lesion, Software Versions: 3.9.0 through 3.9.5.
Reason
Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.
Code Info
Software Versions: 3.9.0 through 3.9.5; UDI-DI: 04260495880396;
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.
Quantity
65 units (13 US, 52 OUS)