Z-0709-2025 Class II Ongoing
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
- 65 units (13 US, 52 OUS)
Product Description
mint Lesion, Software Versions: 3.9.0 through 3.9.5.
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: 3.9.0 through 3.9.5; UDI-DI: 04260495880396;