mint Lesion recall: Software Issue
mint Lesion, Software Versions: 3.10.0 and 3.10.1.
Why was mint Lesion recalled?
Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software Versions: 3.10.0 and 3.10.1; UDI-DI: 04260495883106;
- Product
- mint Lesion, Software Versions: 3.10.0 and 3.10.1.
- Recalling firm
- Mint Medical GmbH
- Quantity
- 18 units (7 US, 11 OUS)
- 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.
- Recall date
- December 25, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)