Facility

NRT X-RAY A/S

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

Key facts

3recalls · 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)	1000188474
Establishment type	Manufacture Medical Device
Location	BIRKEGAARDSVEJ 16 HASSELAGER Midtjylland, DK 8361
Registration status	Active · expires 2026
Parent company	NRT X-RAY A/S (owner-operator 9059076)
Brand names	Intelli C

Activity by year

Recalls (3)
Inspections (1)

Devices registered here (2)

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

Recalls & enforcement

Class IIOngoing2024-04-17
X-ray system C-arm may experience uncontrolled motion if 1) AC motor controller firmware has a faulty setting, 2) the Motor/gear assembly is worn, 3) CAT movement is driven at maximum speed and angulated more than 75 deg. from vertical, and 4) the emergency stop or touch guard is…
Class IIOngoing2023-04-27
There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray machine may break which causes the detector to move until it is stopped by the movement end-stop.
Class IIOngoing2022-01-21
Friction rubber block in the clamping mechanism was missing in the Footrest. It may slip down along the patient table while in use with a patient. This accessory is designed to use with Intelli-C, Right and Intelli-C, Left.

FDA inspections (1)

VAI2023-03-24
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act · 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 NRT X-RAY A/S

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. “NRT X-RAY A/S (FEI 1000188474) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000188474-nrt-x-ray-a-s/

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