| TGA Action ID |
RC-2026-RN-00848-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Philips Allura Xper R8.1.x and R8.2.x systems with FlexVision monitor
Allura Xper FD10
Models: 722003, 722010, 722026
Allura Xper FD10/10
Model: 722027
Allura Xper FD20
Models: 722012, 722028
Allura Xper FD20/15
Model: 722058
Allura Xper FD20 BIPLANE
Models: 722013, 722035
Allura Xper FD20 OR TABLE
Model: 722023 |
| 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 a software problem that may cause the FlexVision software application to become unresponsive during clinical use. When this occurs, the FlexVision monitor may either:
· turn blank and no longer display live images or other information shown on the FlexVision monitor; or
· freeze on the last displayed screen and no longer update live images or other information shown on the FlexVision Monitor.
A blank or frozen FlexVision monitor may contribute to a delay of therapy. Additionally, when the FlexVision monitor freezes on the last displayed screen, the displayed image may appear valid while no longer reflecting the current clinical situation. This may not be recognised immediately and could result in procedural complications, and/or inadequate or inappropriate treatment.
A cold system restart is required to restore normal FlexVision display functionality. To date, Philips has received one report of death potentially associated with this problem. |
| Instructions for Customers/Users |
Philips will implement a software correction to address the problem.
In the interim, customers may continue to use affected systems in accordance with their intended use, subject to the following:
- If the FlexVision monitor becomes blank or freezes on the last displayed screen during a procedure, suspend image-guided device manipulations, and perform a cold system restart following the steps described in the Instructions for Use
- If you experience this problem, report it to your local Philips representative and the TGA via a Medical Device Incident Report. |
| Action Commencement Date |
28/10/2026 |
| Responsible Entity |
|
| Contact Information |
1800 251 400 - Philips Service Delivery Team |