| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00089-1 |
| Product Name/Description |
DuraDiagnost X-ray System
ARTG Number: 207424 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
30/01/2015 |
| Responsible Entity |
|
| Reason/Issue |
During recent evaluations of the Philips DuraDiagnost X-Ray system, Philips have identified a potential issue that may affect the performance of the equipment under certain conditions.
1) If all six T-Nuts which are used to mount the X-ray tube arm base to the carriage were not properly assembled, the tube arm assembly could fall.
2) If all eight T-Nuts which are used to mount the wall stand detector carrier box and base were not properly assembled, the wall stand detector carrier assembly could fall.
3) If all eight T-Nuts which are used to mount the table base and table top floating frame were not properly assembled, the table top could be floating. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A Philips Service Engineer will conduct an inspection to determine if the equipment is affected by this issue. If it is determined that the tube arm and wall stand fixture are not in the correct position the equipment should cease to be used until the tube arm and wall stand fixture have been replaced. A new tube arm and wall stand fixing structure that is designed to prevent this hazard if the tube arm or Wall stand is incorrectly reinstalled in the future will be fitted. This action has been closed-out on 18/07/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |