Focalyx Fusion
Recall
- Recall Number
- Z-1243-2026
- Event Number
- 98137
- Firm
- Focalyx Technologies, LLC.
- FEI Number
- 3016567400
- Product Code
- LLZ
- Status
- Open, Classified
- Root Cause
- Software change control
- Initiated
- December 23, 2025
- Posted
- February 3, 2026
- Address
- 2140 W 68th St, Ste 204, Hialeah, FL, 33016-1815
Description
Focalyx Fusion
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.
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 [email protected] If there are any questions, contact the firm at: focalyxtechnologies.com/contact, [email protected], (888) 636 2259, (Sel. 3 Technical Support)
Worldwide - US Nationwide distribution in the states of NY, MA, FL and the countries of ES, VE, DO.
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