| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00546-1 |
| Product Name/Description |
Philips Spectral CT 7500
Product code: 728333
Unique Device Identifier: (01) 00884838101111
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 |
14/06/2023 |
| Responsible Entity |
|
| Reason/Issue |
Philips has identified an issue with the patient intercom on Philips Spectral CT 7500 systems that could affect the performance of the equipment. The patient cannot be clearly heard by the operator through the intercom on the CT Box in the operation room. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
The system can continue to be used in accordance with the intended use. But customers are to check and adjust the speaker volume of the intercom for the optimal bi-directional communication between the patient and the console operator.
Philips will contact customers to schedule a time for a Philips Field Service Engineer to visit sites and install the solution to improve clinical experience. |
| Contact Information |
1800 251 400 - Philips Service Delivery Team |