| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00458-1 |
| Product Name/Description |
Philips IQon, iCT, Ingenuity and Brilliance CT 64 systems
Software versions: 4.1.10.x and 4.7.7.x
Multiple product codes
ARTG 321687
(Philips Electronics Australia Ltd - X-ray system, diagnostic, computed tomography, full-body |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
26/05/2023 |
| Responsible Entity |
|
| Reason/Issue |
Philips has identified multiple software issues affecting Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems. Issues include brighter preview images for standard resolution head scan, unable to load a customised Exam Card after upgrade, update acceptance and constancy test procedure, general slowness during stress validation test, certain ECG gated EC not possible after upgrade and neck scan types with high resolution, 0.67 mm thickness is incorrectly enabled.
The issues have no clinical impact. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
To identify if the system is affected, the product model name and product code on the back of the gantry in the bottom right corner.
To identify the software version of the product:
1.Click the Help button.
2.Select About and the software version is then displayed. The software version begins with v.
Phillips will contact customers to schedule a Phillips Field Service Engineer to visit sites to install the software update required. Until the update is installed, the appendix within the customer letter has detailed workaround instructions to follow for each affected device. |
| Contact Information |
1800 251 400 - Philips Service Delivery Team |