Official recall record
Focalyx Fusion
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-12-23
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00860003552001
- Brand on record
- Focalyx Technologies, LLC.
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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