Focalyx Fusion
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | December 23, 2025 |
| Reported | February 11, 2026 |
| Recalling firm | Focalyx Technologies, LLC. |
| Country / region | United States FL |
Hazard
Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, which may cause patient harm during biopsy or cause treatment/therapy delays, so firm is recommending stop use until device is verified/validated with Windows 11.
Affected products
- Focalyx Fusion
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