mint Lesion, Software Versions: 3.9.0 through 3.9.5.
Reported: December 25, 2024 Initiated: November 15, 2024 #Z-0709-2025
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.
Details
- Recalling Firm
- Mint Medical GmbH
- Units Affected
- 65 units (13 US, 52 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.
- Location
- Dossenheim
Frequently Asked Questions
What product was recalled? ▼
mint Lesion, Software Versions: 3.9.0 through 3.9.5.. Recalled by Mint Medical GmbH. Units affected: 65 units (13 US, 52 OUS).
Why was this product recalled? ▼
Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 25, 2024. Severity: Moderate. Recall number: Z-0709-2025.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11