Recall Z-1243-2026— Focalyx Technologies, LLC.
Class II · Ongoing
Class II FDA medical device recall by Focalyx Technologies, LLC., initiated 2025-12-23. It names one FDA 510(k) clearance: K170250. Product: Focalyx Fusion. Reason: 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..
- Recalling firm
- Focalyx Technologies, LLC.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-12-23
- Firm location
- Hialeah, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.