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.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Focalyx Technologies, LLC. or your healthcare provider for instructions. Notification method: Letter
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The Focalyx Fusion software device is designed for image-guided interventional and diagnostic procedures involving the prostate. The recall affects 18 units distributed worldwide, including New York, Massachusetts, Florida, Spain, Venezuela, and the Dominican Republic.
The software may not function correctly with Windows 10, posing a high risk of patient harm during biopsy procedures. This malfunction could lead to treatment delays and complications.
No specific incidents or injuries have been reported at this time. The recall is proactive, addressing potential risks before any harm occurs.
Patients and healthcare providers should immediately stop using this device. Follow the manufacturer’s instructions for recall procedures. Contact Focalyx Technologies or your healthcare provider for further guidance.
For more information, visit the Focalyx Technologies website or call their customer service line. More details are also available through the FDA's recall page.
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