| TGA Action ID |
RC-2025-RN-00552-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Azurion 7 M20 system
Distribution dates: October 2018 - July 2019
System code: 722079 |
| ARTG Number |
225815 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Philips has identified a problem with the bolts connecting the gearbox to the mounting flange of the C-arm roll motor.
It has been discovered that these bolts may not have been adequately torqued. If this is the case, over time, the bolts may become loose and cause minor shift movements of the gearbox in relation to the mounting flange. These movements can result in unexpected noise during the C-arm roll motion.
If the bolts continue to loosen, repeated rotation movements can lead to fatigue and potential breakage of the bolts. In such a scenario, the C-arm may rotate freely until the tube reaches its lowest position.
Philips has not received any complaints or reports of adverse events associated with this problem. |
| Instructions for Customers/Users |
Customers are to:
· Know that Philips will replace the C-arm roll motor in all affected systems free of charge.
· Expect a visit from Philips representative to schedule a visit of a Field Service Engineer to perform this activity.
· Be informed that Philips expects the solution to be released in July 2025. .
This action has been closed out on 20/10/2025 |
| Action Commencement Date |
17/06/2025 |
| Responsible Entity |
|
| Contact Information |
1800 251 400 - Service Delivery Team |