| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01299-1 |
| Product Name/Description |
Precision 500D, Legacy, Prestilix, Monitrol, RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Prestige SII (diagnostic fluoroscopic x-ray systems)
All CRT monitors installed from January 1993
ARTG Number: 99423 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
9/12/2013 |
| Responsible Entity |
|
| Reason/Issue |
It has been identified during several Preventive Maintenance activities that the 4 outer screws that hold the overhead Video Monitor Suspension to the carriage were found missing since installation of the system. There is a potential that the systems have not been installed per specified installation requirements. GE Healthcare is not aware of any fall of the overhead monitor suspension; however, missing screws may increase the risk for fall of the monitor suspension. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is inspecting all potentially affected systems to verify the overhead Video Monitor Suspensions are properly installed and will correct all affected systems. |
| Contact Information |
1800 659 465 - GE National Call Centre |