Focalyx Fusion software versions 1.3, 1.5, and 1.6 may not work properly with Windows 10, risking patient harm during prostate procedures. Affected units should stop use until verified 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.
Focalyx Fusion software versions 1.3, 1.5, and 1.6 are recalled because they may not function correctly with Windows 10, potentially causing harm during prostate biopsies or delaying treatments. Users should stop using the device until it is verified with Windows 11.
The software may not function properly with Windows 10, leading to potential patient harm during biopsies or treatment delays. This occurs because the device relies on specific software compatibility for safe medical procedures.
Medical professionals using Focalyx Fusion for prostate procedures with affected software versions are at risk. Patients undergoing biopsies or treatments with these devices could face harm or delays.
Check for software versions 1.3, 1.5, or 1.6 on the Focalyx Fusion device. Affected units have specific serial numbers listed in the recall notice.
Immediately stop using the Focalyx Fusion device if it has software versions 1.3, 1.5, or 1.6.
Ensure the device is updated to Windows 11 compatibility before use.
Software versions 1.3, 1.5, and 1.6 are affected.
Check for the specific serial numbers listed in the recall notice or software versions 1.3, 1.5, or 1.6.
The recall does not mention returning the device; users should stop using it until verified with Windows 11.
We’ve drafted a message you can send Focalyx to request your refund or repair — edit it as you like.
Subject: Recall Z-1243-2026 — Focalyx Focalyx Hello, I own a Focalyx that is covered by recall Z-1243-2026 from Focalyx. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
