| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00300-1 |
| Product Name/Description |
Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems
Multiple model numbers, product codes, device identifiers and software versions
ARTG 321687
(Philips Electronics Australia Ltd - X-ray system, diagnostic, computed tomography, full-body) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/04/2024 |
| Responsible Entity |
|
| Reason/Issue |
Philips has identified multiple software defects affecting Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems. Investigation commenced due to complaints relating to the Bolus Tracking (BT) Algorithm. The BT was observed to perform extra shots after the threshold was reached in two separate incidents.
These defects may lead to hazards including patient exposure to radiation energy/ accidental or unwanted ionizing radiation.
Philips has not received any reports of injury or serious harm associated with these defects. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers to identify the affected product model name and product code on the back of the gantry.
Philips will schedule a time with customers for a Field Service Engineer (FSE) to visit customer's site and install the software update to resolve the issues. A workaround is detailed in the customer letter provided to affected customers, until the software update is installed. |
| Contact Information |
1800 251 400 - Philips Service Delivery Team |