Summary
The FDA issued a Class II for mint Lesion, Software Versions: 3.9.0 through 3.9.5. by Mint Medical GmbH. Reason: Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images..
Details
Source
Device Recall
External ID
Z-0709-2025
Action Date
2024-12-25
Status
Ongoing
Category
device
Product Description
mint Lesion, Software Versions: 3.9.0 through 3.9.5.
Lot/Code Info: Software Versions: 3.9.0 through 3.9.5; UDI-DI: 04260495880396;
Quantity Affected: 65 units (13 US, 52 OUS)
Reason for Recall
Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-15
Company
Dossenheim
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 157 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Mint Medical GmbH has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Mint Medical GmbH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mint Medical GmbH have FDA actions?
Mint Medical GmbH has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0709-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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