FDA Medical devices recall ·
mint Lesion, Software Versions: 3.10.0 and 3.10.1 recall
- Recall number
- Z-0710-2025
- Date
- (initiated November 15, 2024)
- Company / brand
- Mint Medical GmbH
Friedrich-Ebert-Str. 2, Dossenheim, Germany - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 18 units (7 US, 11 OUS)
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
mint Lesion, Software Versions: 3.10.0 and 3.10.1.
Why was it recalled?
Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Software Versions: 3.10.0 and 3.10.1; UDI-DI: 04260495883106;
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.
States: Arkansas California Florida Georgia Michigan Minnesota New York Ohio Pennsylvania Tennessee Texas Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0710-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.