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Focalyx recalls
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Focalyx and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-02-11FDA-DeviceClass IIStop using Focalyx Fusion software
Focalyx Fusion, a software device used to guide prostate biopsies and diagnostic procedures, may not work properly on Windows 10 operating systems. This malfunction could harm patients during biopsy or delay needed treatment. The manufacturer recommends stopping use of affected software versions until the device is confirmed to work with Windows 11.
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