| TGA Action ID |
RC-2026-RN-00682-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Philips CT Rembra systems
Reference: 728381
Software version 6.0.0.X |
| 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 CT Rembra software version 6.0.0.X.
Problems:
1. 6.0.0.X - ECG-gated cardiac axial scan image reconstruction failure
2. 6.0.0.X - Distance between inner and outer lasers changes when gantry is tilted
3. 6.0.0.X - Tracker aborts with auto voice setting
4. 6.0.0.14420 - Reconstruction failure with STD-QA exam card
5. 6.0.0.X - Bad detectors cannot be automatically added into the Bad Detector Table
6. 6.0.0.X - Clinical scan startup not prohibited with insufficient tube heat capacity
7. 6.0.0.X - CDM board may present corrupted data:
These problems may result in reconstruction failures, scan interruptions, image artifacts, positioning inaccuracies, or corrupted images.
To date there have been no injuries /rescan associated with these problems. |
| Instructions for Customers/Users |
Customers may continue to use their system(s) in accordance with the guidance provided in the customer letter. Philips has identified the affected installed base and will contact you to provide a software update to resolve these problems (reference FCO72800855). |
| Action Commencement Date |
7/09/2026 |
| Responsible Entity |
|
| Contact Information |
1800 251 400 - Philips Service Delivery Team |