Focalyx Technologies Recalls

1 recall found for Focalyx Technologies. Check if any of your products are affected.

HIGHFDA DEVICE

Dec 23, 2025

Focalyx Technologies Recalls Software Device Over Patient Safety Risks

Focalyx Technologies issued a recall for its Focalyx Fusion software device on December 23, 2025. The device may malfunction with Windows 10, potentially causing patient harm during prostate biopsies. Users must stop using the device immediately until it is validated with Windows 11.

Focalyx Technologies

Software device

Brand Statistics

Total Recalls

Pages