| TGA Action ID |
RC-2026-RN-00899-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Philips Azurion Systems
Azurion 7 B12
Product Number: 722067
Azurion 7 B20
Product Number: 722068
Azurion 7 M12
Product Numbers: 722078, 722223
Azurion 7 M20
Product Number: 722079, 722224
Azurion 5 M12
Product Number: 722227 |
| ARTG Number |
225815, 370112 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The Power Distribution Unit is an internal assembly of the Philips Azurion system that contains multiple power supplies. Philips has identified that, in certain Azurion systems, one or more of these power supplies can fail due to energy peaks (surge voltages) during start or restart of the system.
When a power supply failure occurs during a start or restart, the Power Distribution Unit does not provide the required direct current power to essential system components. As a result, the system does not successfully complete the (re-)start, imaging functionality is unavailable, and the system remains unavailable for clinical use.
Loss of imaging during clinical use may result in, or contribute to, procedural complications and/or delay of therapy. A delay of therapy in the population requiring urgent interventions may contribute to further deterioration of their condition, which may potentially lead to death. To date, Philips has not received any report of serious injury potentially associated with this problem. |
| Instructions for Customers/Users |
Customers:
· Should when planning clinical procedures, particularly urgent or time-critical interventions, consider the potential consequences of unexpected system unavailability and the availability of alternative imaging or treatment options, where clinically appropriate.
· May continue to use the affected systems in accordance with their intended use whilst they wait for the remediation for this problem.
· Ensure this notice is distributed to all relevant users and retained with the device documentation until corrective actions are completed.
· If you experience a problem described in this letter, please report it to your local Philips representative, and the TGA via a Medical Device Incident Report. A Philips representative will replace the affected product to restore full redundancy.
Philips will replace the existing Power Distribution Unit assembly with a redesigned assembly that includes power-supply redundancy. Philips currently expects the redesigned Power Distribution Unit to be available by Q2 2028. Philips will send an updated communication at this time, and your local Philips representative will contact you to schedule a visit for implementation of the correction once it becomes available. |
| Action Commencement Date |
9/11/2026 |
| Responsible Entity |
|
| Contact Information |
1800 251 400 - Philips Service Delivery Team |