Facility

TRACKX TECHNOLOGY Inc.

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

Key facts

2recalls · worst Class II

1inspections · 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)	3014391847
Establishment type	Manufacture Medical Device
Location	437 Dimmocks Mill Rd Ste 28 Hillsborough, NC, US 27278
Registration status	Active · expires 2026
Parent company	TrackX Technology Inc. (owner-operator 10057101)
Brand names	TrackX

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (3)

System, X-Ray, Fluoroscopic, Image-Intensified
Product code JAA (opens in a new tab) · Class II · Radiology · 21 CFR 892.1650
Interventional Fluoroscopic X-Ray System
Product code OWB (opens in a new tab) · Class II · Radiology · 21 CFR 892.1650
System, Image Processing, Radiological
Product code LLZ (opens in a new tab) · Class II · Radiology · 21 CFR 892.2050

Recalls & enforcement

Class IIIOngoing2024-09-03
The patient label stickers may have the wrong expiration date recorded. The contract manufacturer entered the manufacturing date (2024-04-01) as the expiration date. The actual expiration date of the product is 2027-04-01. This is reflected on the carton label and sterile pouch l…
Class IITerminated2022-10-24
The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted.

FDA inspections (1)

VAI2024-08-14
Voluntary Action Indicated · Compliance: Devices · citations posted

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 TrackX Technology Inc.

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. “TRACKX TECHNOLOGY Inc. (FEI 3014391847) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3014391847-trackx-technology-inc/

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