| TGA Action ID |
RC-2025-RN-00865-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Philips CT 5300 and Incisive CT
Software Versions's: 5.1.0.X & 5.1.1.X
Product Codes: 728143, 728144, 728285
UDI: (01)00884838085015, (01)00884838105508, (01)00884838113237 |
| ARTG Number |
352131 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Philips has identified problems affecting Incisive CT and CT 5300 systems running software version V5.1:
1. Unexpected OnPlan (gantry control panel) simultaneous buttonuse
When locating the patient by OnPlan on the CT gantry, the gantry / couch will keep moving until stopped by its limitation or by manual stop of operator (press the emergency stop button or repress the original motion button), if the below steps occur in this sequence:
- press the motion button from OnPlan without releasing it;
- touch the move display hide bar button (refer to figure 1) at the same time;
- stop pressing the motion button from OnPlan.
The additional Gantry or table motion may cause pain, abrasions, or lacerations.
2. Additional software problems
Philips has identified other software problems (refer to Customer Letter) that may impact clinical workflow and may result in additional radiation exposure or require rescanning. |
| Instructions for Customers/Users |
Philips will arrange for a Field Service Engineer (FSE) to install the solution onsite.
Customers are to continue use of the system in accordance with the intended use and by following the recommendations listed below:
- Avoid touching the “move display hide bar button” while pressing the motion button from OnPlan for gantry / couch. Use any of Emergency STOP buttons if unintended couch or gantry motion occurs.
- Always monitor patient during Onplan motion.
Refer to Table 1 of the Customer Letter for specific details regarding other problems and recommended actions.
This action has been closed out on 17/06/2026 |
| Action Commencement Date |
16/10/2025 |
| Responsible Entity |
|
| Contact Information |
1800 251 400 - Philips Service Delivery Team |