Focalyx Technologies, LLC. recalls Focalyx Fusion

Focalyx Fusion, a software accessory (UDI-DI 00860003552001; Software versions 1.3, 1.5, 1.6; listed serial numbers) used for image-guided interventional and diagnostic prostate procedures, is being recalled for 18 units distributed in the US (NY, MA, FL) and in Spain, Venezuela and the Dominican Republic. The recall was issued because the accessory may not function properly with Windows 10, which may cause patient harm during biopsy or cause treatment/therapy delays; the firm recommends stopping use until the device is verified/validated with Windows 11.

What's being recalled

Focalyx Fusion

Recalling firm: Focalyx Technologies, LLC., Hialeah, FL, United States.

How to identify it

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

The 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.

What to do

Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.

The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.

Where it was sold

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

The official notice

This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.

Read the official notice (opens in a new tab)