Focalyx Technologies, LLC. recalls Focalyx Fusion

Recall date

December 23, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1243-2026

FDA classification

Class II

Brand / firm

Focalyx Technologies, LLC.

Sold / distributed

Worldwide - US Nationwide distribution in the states of NY, MA, FL and the countries of ES, VE, DO.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Focalyx Fusion