Facility

FOCALYX TECHNOLOGIES

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

2inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3016567400
Establishment type	Manufacture Medical Device
Location	2140 W 68th St Ste 406 Hialeah, FL, US 33016
Registration status	Active · expires 2026
Parent company	Focalyx Technologies (owner-operator 10062693)
Brand names	Smartblate; Focalyx Fusion

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (1)

System, Image Processing, Radiological
Product code LLZ (opens in a new tab) · Class II · Radiology · 21 CFR 892.2050

Recalls & enforcement

Class IIOngoing2025-12-23
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 …

FDA inspections (2)

NAI2025-12-01
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2023-08-14
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Focalyx Technologies

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “FOCALYX TECHNOLOGIES (FEI 3016567400) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3016567400-focalyx-technologies/

Not open yet

Alerts for FOCALYX TECHNOLOGIES

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.