FDA DevicesClass II
Focalyx Fusion
Published: February 11, 2026Recall ID: Z-1243-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
Focalyx Fusion
Additional Source Details
| Field | Value |
|---|---|
| City | Hialeah |
| State | FL |
| Event id | 98137 |
| Address 1 | 2140 W 68th St Ste 204 |
| Address 2 | N/A |
| 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 |
| Postal code | 33016-1815 |
| Report date | 20260211 |
| Product type | Devices |
| Product quantity | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251223 |
| Initial firm notification | Letter |
| Center classification date | 20260203 |
Overview
- Recalling FirmFocalyx Technologies, LLC.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide distribution in the states of NY, MA, FL and the countries of ES, VE, DO.