Medical Device

Focalyx Fusion

Recall date: 2026-02-11 · Source: FDA_DEVICE

Brand / Firm

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.

Units affected

Description

Focalyx Fusion

View official recall notice →