FDA recall Z-1243-2026

Product

Focalyx Fusion

Reason for recall

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.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2025-12-23

Report date

2026-02-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hialeah, FL, United States

Primary source

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