Recall Z-1243-2026 ยท LLZ System, Image Processing, Radiological
Focalyx Technologies, LLC.
Focalyx Fusion
| Date | Feb 3, 2026 (initiated Dec 23, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Software change control |
| Action | On 12/23/2025, correction notices started being emailed to customers informing them of the following: You will be contacted to schedule installation of the new version. An IFU will be provided at time of installation. Complete and return the response form via email to corporate@focalyx.com If there are any questions, contact the firm at: focalyxtechnologies.com/contact, support@focalyxtechnologies.com, (888) 636 2259, (Sel. 3 Technical Support) |
| Quantity | 18 |
| Distribution | Worldwide - US Nationwide distribution in the states of NY, MA, FL and the countries of ES, VE, DO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170250 | SmartTarget Smarttarget, Ltd., Jun 7, 2017 |