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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Focalyx Fusion is a software device used as an accessory for image-guided interventional and diagnostic procedures concerning prostate health. It is typically utilized in medical settings to assist in biopsy procedures and other diagnostic functions.
This device may not operate properly with Windows 10, which could lead to significant risks during medical procedures such as biopsies. Such malfunctions could delay treatment and lead to adverse patient outcomes.
This recall is not part of a broader industry pattern.
Patients and healthcare providers may face delays in procedures, which could impact treatment schedules and health outcomes.
Serial numbers and software versions can typically be found on the device's packaging or user manual.
Expect a refund or replacement to be processed within 4-6 weeks after your request.
Keep a record of any communications with the manufacturer and retain all documentation related to the recall.
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.
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