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.
This recall has been terminated (originally issued February 24, 2016).
- Company
- Regulatory Insight, Inc
- Recall Initiated
- July 1, 2008
- Posted
- February 24, 2016
- Terminated
- July 11, 2017
- Recall Number
- Z-0753-2016
- Quantity
- 43
- Firm Location
- Littleton, CO
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Distribution to the states of :TN, CA, WA, OR, PA, WI, FL, MN, VT, NY, NV, MA, CO, IN, MI, MS and OH.
Lot / Code Info
NRT no.: 02980000
Root Cause
Radiation Control for Health and Safety Act
Action Taken
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.