| TGA Action ID |
RC-2025-RN-00500-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Incisive CT and CT 5300
Model Numbers: 728143, 728144, 728285
Serial Numbers: 500408, 550187, 550241, 800028
UDI: (01)00884838105508(21), (01)00884838085015(21), (01)00884838113237(21) |
| ARTG Number |
352131 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The HIB-CIB cable on the NOAH couch may wear unexpectedly over time. During vertical couch motion, if the HIB-CIB cable has been damaged, the system may engage the Emergency Stop intermittently. If the Emergency Stop is engaged both motion and X-rays will stop.
If this occurs during a scan it could result in a partial set of images, and a patient rescan may be required. |
| Instructions for Customers/Users |
Customers may continue to use the Philips CT system(s) in accordance with the intended use.
If customers experience the Emergency Stop opening intermittently during vertical couch motion and cannot be solved by restarting, they should contact the Philips Service Delivery Team on 1800 251 400 for further support.
Philips will contact customers to schedule a time for a Philips Field Service Engineer (FSE) to visit the site and install the solution to resolve this problem.
This action has been closed out on 30/03/2026 |
| Action Commencement Date |
28/05/2025 |
| Responsible Entity |
|
| Contact Information |
1800 251 400 - Philips Service Delivery Team |