Mint Medical GmbH: Device Recall
Recall #Z-0710-2025 · 11/15/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0710-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Mint Medical GmbH
- Status
- Ongoing
- Date Initiated
- 11/15/2024
- Location
- Dossenheim, Germany
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 units (7 US, 11 OUS)
Reason for Recall
Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.
Product Description
mint Lesion, Software Versions: 3.10.0 and 3.10.1.
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.
Other Recalls by Mint Medical GmbH
- Class II: Risk 11/15/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.