| TGA Action ID |
RC-2025-RN-00620-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Philips Allura R8.2.x System
System Codes: 722026, 722027, 722028, 722035, 722058 |
| ARTG Number |
225815 |
| Unique Device Identifier (UDI) |
722026 722027 722028 722035 722058 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| 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.
Situation 2 – Phase Fault: When a phase fault occurs, the X-ray generator software initiates an automatic recovery process to restore fully 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 this situation, the system shows the user message "Generator is busy starting up, no X-ray possible". If the phase fault is detected by the generator during acquisition, the system also shows the message “Run Aborted: Tube Problem”.
Loss of imaging (X-ray) functionality caused by the software problem in either of the two situations could result in a delay of therapy.
Philips has received:
-No complaints related to the Pedal Tap situation.
-Two complaints related to the Phase Fault situation. None of these complaints reported any harm to the patient. |
| Instructions for Customers/Users |
Philips will provide a software update to all affected systems. Customers will be contact by their Philips Representative to schedule a visit to install the software update.
Philips expects to have the updated software released by Q3 2025. |
| Action Commencement Date |
9/07/2025 |
| Responsible Entity |
|
| Contact Information |
1800 251 400 - Philips Service Delivery Team |