| TGA Action ID |
RC-2026-RN-00326-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Philips Allura and Azurion Systems
Product Names: Allura Xper FD10, Allura Xper FD20, Allura Xper FD20/15, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20
Model Numbers: 722010, 722026, 722006, 722028, 722058, 722067, 722068, 722078, 722079 |
| ARTG Number |
225815 |
| Unique Device Identifier (UDI) |
N/A |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Philips has identified that the deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message “Low load fluoroscopy flavor selected: Tube cooler problem”. This condition cannot be resolved by restarting the system. Under normal conditions, any leaked oil is contained within the system. In rare cases of more significant leakage, oil may extend beyond the intended containment area. If oil then comes into contact with hot surfaces, fumes may be generated. These fumes may activate environmental detection systems.
To date, no harm to patients, users, or service personnel has been reported in relation to this problem. |
| Instructions for Customers/Users |
- Customers may continue to use the system following the Instructions for Use
- If customers experience the problem, please report it to a local Philips representative.
- Starting in Q1 2027, Philips will replace the deaeration hose in the CU3101 tube cooling unit in all affected systems. |
| Action Commencement Date |
4/05/2026 |
| Responsible Entity |
|
| Contact Information |
1800 251 400 - Philips Service Delivery Team |