Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Focalyx Fusion Recalled by Focalyx Technologies, LLC. Due to Software device that is an accessory for image-guided...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Focalyx Technologies, LLC. directly.
Affected Products
Focalyx Fusion
Quantity: 18
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Focalyx Technologies, LLC.
Focalyx Technologies, LLC. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report