FDA-Device2026-02-11Class II

Focalyx Fusion

Focalyx Technologies, LLC.

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

Original summary

Focalyx Fusion 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. UDI-DI: 00860003552001. Software Versions: 1.3, 1.5, 1.6. Serial Numbers: IF-FF-B-1-22080504, IF-FF-B-1-TPAA998118, IF-FF-B-1-351238, IF-FF-B-1-TPAB081335, IF-FF-B-1-22080508, IF-FF-B-1-TPAB200331, IF-FF-B-1-TPAB200333, IF-FF-B-1-TPAC505383, IF-FF-B-1-TPAB200348, IF-FF-B-1-TPAB540364, IF-FF-B-1-S5ARQL009253NYZ, IF-FF-B-1-SCARQL0014096YZ, IF-FF-B-1-TPAB532163, IF-FF-B-1-SCARQL00136033KK, IF-FF-B-1-TPAB540359, IF-FF-B-1-TPAB081326, IF-FF-B-1-22080505, IF-FF-B-1-TPAB081324 Distribution: Worldwide - US Nationwide distribution in the states of NY, MA, FL and the countries of ES, VE, DO. Affected quantity: 18

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