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FDADecember 23, 2025device

Focalyx Fusion

Official recall recorded by the U.S. Food & Drug Administration.

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

FDA enforcement status: Ongoing

Brands named

focalyx technologiesfocalyx

UPCs

00860003552001

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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