| TGA Action ID |
RC-2026-RN-00687-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Philips Spectral CT with software version V5.0, V5.2, or V5.4
Product Code: 728333
Device Identifier: (01)00884838101111 |
| ARTG Number |
321687, 423851 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Five (5) problems have been identified with Philips Spectral CT with software version V5.0, V5.2, or V5.4
1. Image artifacts at 80kVp.
2. Image quality problem with brain scans.
3. Wrong slice thickness with extended field of view (EFOV).
4. Couch incorrect motion during interventional procedure.
5. Unexpected rotor rotation during service. |
| Instructions for Customers/Users |
Philips will contact users to provide a software update to resolve this problem (reference FCO72800860). Customers with affected systems will be contacted during Q3 or Q4 2026 to schedule implementation of the software update. Customers may continue to use their system(s) in accordance with the recommendations outlined in the Customer Letter. |
| Action Commencement Date |
25/09/2026 |
| Responsible Entity |
|
| Contact Information |
1800 251 400 - Philips Service Delivery Team |