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Focalyx Technologies, LLC. recalls Focalyx Fusion
Recalled February 11, 2026 · FDA recall Z-1243-2026 · Focalyx Technologies
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. · FDA Class II
Units
18
Sold at
Worldwide - US Nationwide distribution in the states of NY, MA, FL and the countries of ES, VE, DO.
Description
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.
Product
Focalyx Fusion
Manufacturer(s)
Focalyx Technologies, LLC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →