| TGA Action ID |
RC-2026-RN-00521-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Philips Azurion and Allura Systems
Product Codes: 722026, 722027, 722028, 722035 |
| ARTG Number |
225815 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Philips has identified that certain Azurion and Allura systems are being operated in combination with Uninterruptible Power Supplies (UPSs) that have not been validated by Philips for use with these systems. As a result, there is potential for interruption of system operation and/or loss of imaging.
This problem may potentially result in or contribute to procedural complications and/or a delay of therapy, potentially resulting in serious adverse health outcomes.
Philips has not received any reports of harm associated with this problem. |
| Instructions for Customers/Users |
Customers are to be aware:
- A Philips representative will be in contact to schedule the applicable activities for each site.
Starting in September 2026, Philips will initiate a phased assessment of the identified UPSs used in combination with Azurion and Allura systems to evaluate their compatibility with Philips system requirements.
Due to the range of UPSs identified in the field, these activities will be conducted progressively.
Based on the outcome of this assessment, additional site-specific verification activities may be performed and, where appropriate, corrective actions may be implemented in coordination with the UPS service provider. |
| Action Commencement Date |
14/07/2026 |
| Responsible Entity |
|
| Contact Information |
1800 251 400 - Philips Service Delivery Team |