FDA-Device2026-02-11Class IIPROCESSING DEFECT

Focalyx Fusion prostate biopsy software recalled for Windows 10 compatibility issue

OTHERNationwide distribution

Stop using Focalyx Fusion software

Focalyx Fusion, a software device used to guide prostate biopsies and diagnostic procedures, may not work properly on Windows 10 operating systems. This malfunction could harm patients during biopsy or delay needed treatment. The manufacturer recommends stopping use of affected software versions until the device is confirmed to work with Windows 11.

Stop using Focalyx Fusion software (versions 1.3, 1.5, or 1.6) immediately if your system runs Windows 10
Contact Focalyx Technologies to verify your device serial number and get an updated version compatible with Windows 11
Do not perform prostate biopsies or interventional procedures using this software until compatibility is confirmed

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.

Sold states

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

Affected count

Manufactured in

2140 W 68th St Ste 204, N/A, Hialeah, FL, United States

Products

Focalyx Fusion

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1243-2026

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