Focalyx Technologies, LLC.: Device Recall
Recall #Z-1243-2026 · 12/23/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1243-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Focalyx Technologies, LLC.
- Status
- Ongoing
- Date Initiated
- 12/23/2025
- Location
- Hialeah, FL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18
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.
Product Description
Focalyx Fusion
Distribution Pattern
Worldwide - US Nationwide distribution in the states of NY, MA, FL and the countries of ES, VE, DO.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.