| TGA Action ID |
RC-2026-RN-00256-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
CT contrast medium injection system, battery-powered (IRIS autoinjector)
Serial Numbers: 2020080038, 2020080032, 2017060157, 2017060006, 2018010077, 2016070027, 2016050028, 2017100096 |
| ARTG Number |
275324 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
A customer reported that the system froze due to a temporary loss of communication within the device. When this occurs, the screen continues to display that an injection is in progress, and the on screen buttons are unavailable. As a result, the user cannot continue or restart the injection using the normal controls and may need to restart the system to restore normal operation. |
| Instructions for Customers/Users |
Facilities should install the software update on their IRIS device. The update ensures the GUI buttons are re-enabled in the event of a communication error, allowing the user to safely reset the injection sequence without the need to power down and reinitialise the entire system. |
| Action Commencement Date |
15/04/2026 |
| Responsible Entity |
|
| Contact Information |
02 9503 8100 - Global Medical Solutions |