Medical Device Recall: Focalyx Fusion
Focalyx Technologies, LLC. · December 23, 2025
Reason for Recall
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.
Distribution
Worldwide - US Nationwide distribution in the states of NY, MA, FL and the countries of ES, VE, DO.
States Affected
NATIONWIDE
Quantity Affected
18
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1243-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.