| TGA Action ID |
RC-2026-RN-00657-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Philips iCT, Ingenuity CT, and Brilliance CT 64 and IQon Spectral CT systems
Software Version: 4.1.10.x and 4.7.7.x
Product Codes: 728306, 728321, 728323, 728326, 728332 |
| ARTG Number |
321687, 423851, 445069 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
During the cardiac scan planning, if the X (XCA, XCB, XCC, XCD) filter for reconstruction is selected, the reconstructed cardiac images may display unexpected noise.
Noisy cardiac images may result in reduced image quality, including recognisable artifacts, anatomy obscured by artifacts, or non-diagnostic images.
To date Philips has not received any reports of injury or patient harm associated with this problem. |
| Instructions for Customers/Users |
Customers may continue to use system(s) in accordance with the intended use, noting that you can use alternative CA, CB, CC, and CD filters and evaluate the image quality during live planning or during offline reconstruction.
Philips will contact customers to schedule a time for a Philips Field Service Engineer (FSE) to visit affected sites and install a software solution (Reference FCO72800857) to resolve the problem. |
| Action Commencement Date |
28/08/2026 |
| Responsible Entity |
|
| Contact Information |
1800 251 400 - Philips Service Delivery Team |