Recall Z-0709-2025— Mint Medical GmbH
Class II · Ongoing
Class II FDA medical device recall by Mint Medical GmbH, initiated 2024-11-15. It names one FDA 510(k) clearance: K142647. Product: 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..
- Recalling firm
- Mint Medical GmbH
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-11-15
- Firm location
- Dossenheim, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.