Class II — Focalyx Technologies, LLC.
| Recalling firm | Focalyx Technologies |
|---|---|
| Registered facility | FOCALYX TECHNOLOGIES (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | Focalyx Fusion |
| Quantity | 18 |
| Distribution | Worldwide - US Nationwide distribution in the states of NY, MA, FL and the countries of ES, VE, DO. |
| Initiated | 2025-12-23 |
| Classified | 2026-02-03 |
| Recall number | Z-1243-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Focalyx Technologies, LLC. (Z-1243-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98137/
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