Regulatory Insight, Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Regulatory Insight, Inc
Lot Codes / Batch Numbers
NRT no.: 02980000
Products Sold
NRT no.: 02980000
Regulatory Insight, Inc is recalling GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of dia due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CO, FL, IN, MA, MI, MN, MS, NV, NY, OH, OR, PA, TN, VT, WA, WI
Page updated: Jan 10, 2026