Z-1243-2026Class II

Focalyx Fusion

Name: Z-1243-2026 Focalyx Fusion
Creator: Focalyx Technologies, LLC.
Published: 2025-12-23
License: https://open.fda.gov/license/

Focalyx Technologies / initiated 2025-12-23 / Open, Classified / root cause: software

FDA source

Focalyx Technologies, LLC. began a recall of Focalyx Fusion on 2025-12-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1243-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-23
Posted: 2026-02-03
Recalling firm: Focalyx Technologies
Product: Focalyx Fusion
Product code: LLZ System, Image Processing, Radiological
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.
Root cause tag: software
FDA root cause: Software change control
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)
Quantity in commerce: 18
Distribution: Worldwide - US Nationwide distribution in the states of NY, MA, FL and the countries of ES, VE, DO.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1243-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1243-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-03

Product code LLZ

K170250Class IISmartTargetSmarttarget, Ltd. / cleared 2017-06-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)