Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

Focalyx Fusion

FDA Recall Z-1243-2026 · Posted 2026-02-03

Recalling FirmFocalyx Technologies, LLC.
Recall StatusOpen, Classified
Product CodeLLZ
Date Initiated2025-12-23
Product Quantity18

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.

Firm 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 [email protected] If there are any questions, contact the firm at: focalyxtechnologies.com/contact, [email protected], (888) 636 2259, (Sel. 3 Technical Support)

Root Cause

Software change control

Distribution Pattern

Worldwide - US Nationwide distribution in the states of NY, MA, FL and the countries of ES, VE, DO.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K170250SmartTargetSmarttarget, Ltd. · 2017-06-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑