Nrt X-ray A/s
BIRKEGAARDSVEJ 16, HASSELAGER Midtjylland, DK
Registered product codes
2 product codes
Recent MDR events
3 on file
Recalls
4 on file
- Open, ClassifiedMay 7, 2024
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 activated during the breaking sequence, which could lead to the C-arm hitting the patient or operator.
View FDA record ↗ - Open, ClassifiedMay 31, 2023
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.
View FDA record ↗ - Open, ClassifiedMay 31, 2023
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.
View FDA record ↗ - Open, ClassifiedUnknown
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.
View FDA record ↗
Compliance history
Matched by FEI 1000188474.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.