Focalyx Technologies Recalls Focalyx Fusion Software Due to Windows 10 Compatibility Risks

What Happened

Focalyx Technologies, LLC. has initiated a voluntary recall of its Focalyx Fusion software device, an accessory used for image-guided interventional and diagnostic procedures involving the prostate. The recall was prompted by findings that certain accessories may not function properly when used with the Windows 10 operating system. This malfunction could potentially cause patient harm during biopsy procedures or result in significant delays in treatment and therapy.

Which Products Are Affected

The recall affects 18 units distributed worldwide, including the U.S. states of New York, Massachusetts, and Florida, as well as Spain, Venezuela, and the Dominican Republic.

• Product Name: Focalyx Fusion
• Recall Number: Z-1243-2026
• Software Versions: 1.3, 1.5, 1.6
• UDI-DI: 00860003552001
• 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

What You Should Do

The firm is recommending that all users stop using the affected devices immediately. Use should only resume once the device has been verified and validated for compatibility with Windows 11. Focalyx Technologies initiated the notification process via letter on December 23, 2025.

Why This Matters

This recall is significant because software errors during prostate biopsies or diagnostic procedures can lead to direct physical harm to the patient or cause critical delays in necessary medical interventions.

Source

Information provided by the FDA.