Mint Lesion Software Data Loss During Server Connection Interruption
Mint Medical is recalling Mint Lesion software versions 3.4.0 through 3.9.5 due to a risk of data loss or incorrect patient data linking when the workstation-to-server connection is interrupted during a read operation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of medical device software with potential for patient harm due to data loss or incorrect patient data linking, which could lead to misdiagnosis or treatment errors. No illnesses or injuries are reported in the source text, but the risk of harm to patients is significant.
Plain-English summary
Mint Medical GmbH is recalling Mint Lesion medical imaging software (versions 3.4.0 through 3.9.5) distributed worldwide, including in the United States and across Europe. The recalled software may experience data loss or incorrectly link information to other patients in rare cases when the connection between a Mint Lesion workstation and the Mint Lesion server is interrupted while performing a read operation.
The defect affects approximately 101 systems globally. Affected healthcare facilities and clinicians using the impacted software versions should contact Mint Medical GmbH for updated software versions that address this issue. The specific Unique Device Identifiers (UDI-DI) for the affected software are: 04260495880341, 04260495880358, 04260495880365, 04260495880372, 04260495880389, and 04260495880396.
The recalled product
- Product
- Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
- Manufacturer
- Mint Medical GmbH
- Hazard
- data-loss
- patient-data-mislinking
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Software Versions: 3.4.0 up to 3.9.5. UDI-DI: 04260495880341
- 04260495880358
- 04260495880365
- 04260495880372
- 04260495880389
- 04260495880396.
Distribution
Distributed nationwide across the United States.