| TGA Action ID |
RC-2026-RN-00694-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Philips Spectral CT Systems
Product Code (REF): 728333
Software Versions: V5.0.x, V5.2.x, V5.4.x |
| ARTG Number |
321687, 423851 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Philips has identified 24 software problems that may affect the performance of certain Spectral CT systems.
Philips has not received any reports of injury or patient harm associated with these problems. |
| Instructions for Customers/Users |
Philips will contact users to schedule a time for a Philips Field Service Engineer (FSE) to visit each site and install a software solution (refer to FCO72800860) to resolve the problems.
In the interim. customers may refer to the manufacturer recommendations in the Customer Letter. |
| Action Commencement Date |
18/09/2026 |
| Responsible Entity |
|
| Contact Information |
1800 251 400 - Philips Service Delivery Team |