| TGA Action ID |
RC-2026-RN-00618-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Incisive CT and CT 5300 with software version 5.1.2.X
REF: 728143, 728144, 728285 |
| ARTG Number |
352131 |
| Unique Device Identifier (UDI) |
N/A |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Philips has identified multiple software problems in software version 5.1.2.X affecting Philips Incisive CT and CT 5300 systems.
These problems may affect system performance and result in image reconstruction failures, image artefacts, scan failures, incomplete image sets, delayed visual breath-hold guidance, incorrect voice prompt settings, or inaccurate positioning guidance during CT-guided procedures.
Philips has not received any reports of harm or injuries associated with these problems as of June 2026. |
| Instructions for Customers/Users |
- Customers may continue to use the system(s) in accordance with the intended use.
- Philips will contact customers to schedule a time for a Philips Field Service Engineer (FSE) to visit and install a software update to resolve these software problems (reference FCO72800853). |
| Action Commencement Date |
14/08/2026 |
| Responsible Entity |
|
| Contact Information |
1800 251 400 - Philips Service Delivery Team |