RegWardenFDA facility compliance records
Company

NRT X-RAY A/S

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

Recalls by year

FDA actions on record by year2022: 1 recalls; 2023: 1 recalls; 2024: 1 recalls2017201820192020202112022120231202420252026
  • Recalls (3)

Registered facilities (1)

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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “NRT X-RAY A/S — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9059076-nrt-x-ray-a-s/

Not open yet

Alerts for NRT X-RAY A/S

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.