| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00540-1 |
| Product Name/Description |
Philips Big Bore RT, Brilliance CT Big Bore and Brilliance CT Big Bore Oncology (software version 4.8.0)
Product Code: 728242, 728244, 728243
UDI: (01)00884838095168, (01)00884838059450, (01)00884838059450
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 |
19/06/2023 |
| Responsible Entity |
|
| Reason/Issue |
Multiple software issues affecting Philips Big Bore RT and Upgrade Brilliance CT Big Bore systems have been identified. These issues may cause the system to shut down unexpectedly or to generate unsatisfactory images, which may result in the need to perform a rescan. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Philips will contact customers to schedule a site visit to install a software update to resolve the issues.
In the interim, customers may continue to use the system(s) in accordance with the intended use. Customers are to refer to the customer letter (supplied by the sponsor to affected customers) for specific details regarding the issue descriptions and recommendations on actions to be taken.
This action has been closed out on 26/07/2024 |
| Contact Information |
1800 251 400 - Philips Service Delivery Team |