Nrt X-Ray A/S FDA Recalls

4 recalls on file across devices, 0 of them Class I and 4 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the InteClass IIApr 17, 2024X-ray system C-arm may experience uncontrolled motion if 1)	X-ray system C-arm may experience uncontrolled motion if 1) AC motor controller firmware has a faulty setting,	Class IIDevices	Apr 17, 2024
Intelli-C, Right side suspended Tabletop, REF: 03400000Class IIApr 27, 2023There is a potential that the drive shaft in the detector up	There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray machine may brea	Class IIDevices	Apr 27, 2023
Intelli-C, Left side suspended Tabletop, REF: 03400010Class IIApr 27, 2023There is a potential that the drive shaft in the detector up	There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray machine may brea	Class IIDevices	Apr 27, 2023
1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combinatiClass IIJan 21, 2022Friction rubber block in the clamping mechanism was missing	Friction rubber block in the clamping mechanism was missing in the Footrest. It may slip down along the patien	Class IIDevices	Jan 21, 2022