Recall Z-0753-2016 ยท OWB Interventional Fluoroscopic X-Ray System
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.
| Date | Feb 24, 2016 (initiated Jul 1, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | 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. |
| Quantity | 43 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033486 | GE PRECISION MPI Nrt-Nordisk Rontgen Teknik A/S, Nov 19, 2003 |