Company: Focalyx Technologies, LLC
Date of Enforcement Report: 2/3/2026
Class: II
PRODUCT:
Focalyx Fusion
Recall Number:
Z-1243-2026
REASON:
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.
RECALLING FIRM/MANUFACTURER:
Focalyx Technologies, LLC
VOLUME:
18
DISTRIBUTION:
Worldwide – US Nationwide distribution in the states of NY, MA, FL and the countries of ES, VE, DO.
