| TGA Action ID |
RC-2025-RN-00629-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Philips Azurion Systems R1.x and R2.x
Model numbers: 722067, 722068, 722078, 722079, 722221, 722223, 722224, 722226, 722227, 722228 |
| ARTG Number |
225815, 370112 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Philips has identified a software problem in the internal communication process between the system software and the X-ray generator firmware. This problem may be triggered under either of the following situations:
Situation 1 - Pedal Tap: When the foot switch is pressed and released rapidly without generating X-rays (due to a short duration of contact), the system may enter a state where X-ray generation is inhibited. When this occurs, the system does not show any message to the user indicating that X-ray is not possible.
Situation 2 – Phase Fault: When a phase fault occurs, the X-ray generator software initiates an automatic recovery process to restore full system functionality, during which imaging (X-ray) functionality is not available for approximately 5 seconds. When the identified software problem occurs during this recovery, communication with the system software is lost, resulting in the system not recognising that the generator has recovered and is ready for operation.
In the period from Dec 2023 to Apr 2025, Philips has received:
- Fifty-four (54) complaints related to the Pedal Tap situation. None of these complaints reported any harm to the patient.
- Six (6) complaints related to the Phase Fault situation. According to one (1) complaint overseas, the procedure was stopped and patient later transferred to a different facility. The patient died two days later. |
| Instructions for Customers/Users |
Philips will address the identified problem by implementing a software and hardware update in all affected systems. A Philips representative will contact customers to schedule a visit to install the software update once available. The update is expected to be available by the end of August 2025.
In the interim, customers are to follow the instructions outlined in the customer letter:
- Avoid rapidly pressing and releasing the footswitch pedals.
- In case X-ray functionality is not available, perform a cold system restart of the system, as follows:
o On the Review Module, press and hold “Power Off”.
o Release the button when the indicator light begins to flash.
o When the indicator light stops flashing, wait for 10 seconds.
o On the Review Module, press and hold “Power On”.
Please note a cold restart takes 6 minutes from initiation of the cold restart until all system functionality is available. X-rays cannot be taken during the cold restart.
Do not operate any of the controls while the system is powering on, as this may inhibit the start-up process. |
| Action Commencement Date |
25/07/2025 |
| Responsible Entity |
|
| Contact Information |
1800 251 400 - Philips Service Delivery Team |