| TGA Action ID |
RC-2026-RN-00233-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems
Software Versions: 4.1.10.x and 4.7.7.x
Product Codes (REF): 728306, 728332, 728321, 728323, 728326, 728231
Device Identifiers (DI): (01)00884838059474, (01)00884838059542, (01)00884838059498, (01)00884838059504, (01)00884838059511, (01)00884838083325
|
| ARTG Number |
321687, 423851, 445069 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
During a bolus-tracking scan, after the user starts the Tracker scan following Surview and Locator acquisitions, the Tracker graph and images may fail to update or display when the contrast agent attenuation (CT value) at the ROI (region of interest) reaches the preset threshold.
As a result, additional Tracker scans may be performed on the patient, and the clinical scan may not automatically start once the threshold is met. If the clinical scan is not manually triggered in time after the Tracker scan reaches the threshold, a rescan may be required.
Philips has not received any reports of injury or harm associated with this problem. |
| Instructions for Customers/Users |
Philips will contact customers to schedule a time for a Philips Field Service Engineer (FSE) to visit sites and install a software solution to resolve the problem.
In the meantime customers may continue to use your system(s) in accordance with the intended use.
As advised in the IFU, “monitor the bolus values on the images during the Tracker scan to ensure the scan is proceeding as planned. During the Tracker scan, if the threshold is not reached, you can manually trigger the Clinical scan by clicking Start scan.” |
| Action Commencement Date |
27/03/2026 |
| Responsible Entity |
|
| Contact Information |
1800 251 400 Philips Service Delivery Team. |