FDAFDA · Food and drugs·Recall number Z-0710-2025
mint Lesion, Software Versions: 3.10.0 and 3.10.1.
Published December 25, 2024 · Recall initiated: November 15, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Mint Medical GmbH
- Distributor
- 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.
- Lot
- Software Versions: 3.10.0 and 3.10.1; UDI-DI: 04260495883106;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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