Summary
The FDA issued a Class II for Focalyx Fusion by Focalyx Technologies, LLC.. Reason: Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not functio.
Details
Source
Device Recall
External ID
Z-1243-2026
Action Date
2026-02-11
Status
Ongoing
Category
device
Product Description
Focalyx Fusion
Lot/Code Info: 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
Quantity Affected: 18
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.
Distribution
Worldwide - US Nationwide distribution in the states of NY, MA, FL and the countries of ES, VE, DO.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-12-23
Company
Hialeah, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 207 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Focalyx Technologies, LLC.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Focalyx Technologies, LLC. have FDA actions?
This is the only FDA action we have on record for Focalyx Technologies, LLC. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1243-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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