Focalyx Fusion
Reported: February 11, 2026 Initiated: December 23, 2025 #Z-1243-2026
Product Description
Focalyx Fusion
Reason for Recall
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.
Details
- Recalling Firm
- Focalyx Technologies, LLC.
- Units Affected
- 18
- Distribution
- Worldwide - US Nationwide distribution in the states of NY, MA, FL and the countries of ES, VE, DO.
- Location
- Hialeah, FL
Frequently Asked Questions
What product was recalled? ▼
Focalyx Fusion. Recalled by Focalyx Technologies, LLC.. Units affected: 18.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 11, 2026. Severity: Moderate. Recall number: Z-1243-2026.
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