Focalyx Fusion recallZ-1243-2026 · Focalyx Technologies, LLC. · initiated Dec 23, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Focalyx Technologies, LLC. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software change control
What the company is doing
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)
Recall details
- Recall number
- Z-1243-2026
- Status
- Open, Classified
- Initiated by the company
- Dec 23, 2025
- Posted by the FDA
- Feb 3, 2026
- Recalling firm
- Focalyx Technologies, LLC.
- Quantity
- 18
- Product code
- LLZ
- FDA submissions
- K170250
- Distribution
- Worldwide - US Nationwide distribution in the states of NY, MA, FL and the countries of ES, VE, DO.
Product description
Focalyx Fusion
Code information (models, lots, serial numbers)
UDI-DI: 00860003552001. Software Versions: 1.3, 1.5, 1.6. Serial Numbers: IF-FF-B-1-22080504, IF-FF-B-1-TPAA998118, IF-FF-B-1-351238, IF-FF-B-1-TPAB081335, IF-FF-B-1-22080508, IF-FF-B-1-TPAB200331, IF-FF-B-1-TPAB200333, IF-FF-B-1-TPAC505383, IF-FF-B-1-TPAB200348, IF-FF-B-1-TPAB540364, IF-FF-B-1-S5ARQL009253NYZ, IF-FF-B-1-SCARQL0014096YZ, IF-FF-B-1-TPAB532163, IF-FF-B-1-SCARQL00136033KK, IF-FF-B-1-TPAB540359, IF-FF-B-1-TPAB081326, IF-FF-B-1-22080505, IF-FF-B-1-TPAB081324
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Focalyx Fusion 1.7Focalyx Technologies, LLC · System, Image Processing, Radiological1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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