Reported Dec 25, 2024 · Ongoing
mint Lesion, Software Versions: 3.9.0 through 3.9.5.
Mint Medical GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mint Medical GmbH · Friedrich-Ebert-Str. 2 · Dossenheim · N/A
Is this the product you have?
- mint Lesion
- Software Versions3.9.0 through 3.9.5
- Lot codes and dates
- Software Versions3.9.0 through 3.9.5
- UDI-DI04260495880396
- Amount recalled
- 65 units (13 US, 52 OUS)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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