FDA
GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.
It was discovered that the Remote Touch Panel (RTP) of the GE Precision MPi X-ray system may not always boot up as intended and needs to be updated to properly accomplish its intended purpose.
Nordisk Rontgen Teknik ( NRT ) Planned action to bring defect into compliance:
1.Nordisk Rontgen Teknik A/S (NRT) will contact customers and initiate a software and hardware update to correct the defect.
2.NRT engineers will install the software and perform testing to ensure the software and hardware update was effective.
3.The customer notification letter which includes a statement that NRT will without charge, remedy the defect or bring the product into compliance.
For further questions please call (720) 962- 5412.