Focalyx Fusion
FDA device recall Z-1243-2026 · posted 2026-02-03 · Open, Classified
Recall details
- Recalling firm
- Focalyx Technologies, LLC.
- 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.
- Action taken
- 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)
- Root cause
- Software change control
- Status
- Open, Classified
- Product code
- LLZ
- Quantity affected
- 18
- Distribution
- Worldwide - US Nationwide distribution in the states of NY, MA, FL and the countries of ES, VE, DO.
- Date initiated
- 2025-12-23
- Date posted
- 2026-02-03
- Location
- Hialeah, FL
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Related 510(k) clearances
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|---|---|---|
| SmartTarget (K170250) | Smarttarget, Ltd. | 2017-06-07 |